From e3fa8ed9e341532851b8c9e8efb5847c3baa4819 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Mon, 27 Jan 2025 12:10:49 -0500 Subject: [PATCH 01/22] initial version of va-spec~ish (in progress) moalmanac --- dereference.py | 417 + moalmanac-draft.dereferenced.json | 111290 +++++++++++++++++++++++++++ referenced/about.json | 8 + referenced/agents.json | 9 + referenced/biomarkers.json | 2590 + referenced/contributions.json | 16 + referenced/diseases.json | 1655 + referenced/documents.json | 1712 + referenced/genes.json | 2652 + referenced/indications.json | 2557 + referenced/organizations.json | 9 + referenced/propositions.json | 11022 +++ referenced/statements.json | 7906 ++ referenced/therapies.json | 890 + 14 files changed, 142733 insertions(+) create mode 100644 dereference.py create mode 100644 moalmanac-draft.dereferenced.json create mode 100644 referenced/about.json create mode 100644 referenced/agents.json create mode 100644 referenced/biomarkers.json create mode 100644 referenced/contributions.json create mode 100644 referenced/diseases.json create mode 100644 referenced/documents.json create mode 100644 referenced/genes.json create mode 100644 referenced/indications.json create mode 100644 referenced/organizations.json create mode 100644 referenced/propositions.json create mode 100644 referenced/statements.json create mode 100644 referenced/therapies.json diff --git a/dereference.py b/dereference.py new file mode 100644 index 0000000..984aa44 --- /dev/null +++ b/dereference.py @@ -0,0 +1,417 @@ +import argparse +import json +import typing + + +class Dereference: + """ + Functions to dereference, depending on the field type to dereference + """ + + @staticmethod + def get_by_key_value(records: list[dict], value: typing.Any, key: str = "id", warn: bool = True) -> list[dict]: + """ + Retrieves records where a specific field matches a given value. + + Args: + records (list[dict]): A list of dictionaries to search. + value (any): The value to match. + key (str): The field to check (default: "id"). + warn (bool): Whether to warn and exit if the number of results is not 1 (default: True). + + Returns: + list[dict]: A list of matching records. + + Raises: + ValueError: If the number of results is not exactly 1 and warnings are enabled. + """ + results = [record for record in records if record.get(key) == value] + + if warn and len(results) != 1: + ValueError(f"Warning: Expected 1 result for {key} == {value}, found {len(results)}.") + + return results + + @classmethod + def integer(cls, records: list[dict], referenced_key: str, referenced_records: list[dict], new_key_name: str) -> list[dict]: + """ + Dereferences a key for each record in records, presuming that the corresponding value is an integer. + + Args: + records (list[dict]): list of dictionaries that require a key to be dereferenced. + referenced_key (str): name of the key in records to dereference. + referenced_records (str): list of dictionaries that the referenced_key refers to. + new_key_name (str): name of the key in records to replace referenced_key after dereference. + + Raises: + KeyError: If the referenced_key is not found in the record. + """ + + dereferenced_records = [] + for record in records: + keys = list(record.keys()) + if not referenced_key in keys: + raise KeyError(f"Key '{referenced_key}' not found in {record}.") + + referenced_record = cls.get_by_key_value( + records=referenced_records, + key='id', + value=record[referenced_key] + ) + referenced_record = referenced_record[0] + + new_record = {} + for key, value in record.items(): + if key == referenced_key: + new_record[new_key_name] = referenced_record + else: + new_record[key] = value + + dereferenced_records.append(new_record) + return dereferenced_records + + @classmethod + def list(cls, records: list[dict], referenced_key: str, referenced_records: list[dict], key_always_present: bool = True) -> list[dict]: + """ + Dereferences a key for each record in records, presuming that the corresponding value is a list. + + Args: + records (list[dict]): list of dictionaries that require a key to be dereferenced. + referenced_key (str): name of the key in records to dereference. + referenced_records (str): list of dictionaries that the referenced_key refers to. + key_always_present (bool): If True, the referenced_key is present in all records. + + Raises: + KeyError: If the referenced_key is not found in the record, despite key_always_present being True. + """ + + for record in records: + if key_always_present and (referenced_key not in record): + raise KeyError(f"Key '{referenced_key}' not found but should be found in {record}") + + if referenced_key not in record: + continue + + _values = [] + for value in record[referenced_key]: + _value = cls.get_by_key_value( + records=referenced_records, + key='id', + value=value + ) + _values.append(_value[0]) + record[referenced_key] = _values + return records + + + @staticmethod + def rename_key(dictionary: dict, old_key: str, new_key: str) -> None: + """ + Renames a key in a dictionary. + + Args: + dictionary (dict): The dictionary to modify. + old_key (str): The key to rename. + new_key (str): The new key name. + + Raises: + KeyError: If the old_key does not exist in the dictionary. + ValueError: If the new_key already exists in the dictionary. + """ + if old_key not in dictionary: + raise KeyError(f"Key '{old_key}' not found in the dictionary.") + + if new_key in dictionary: + raise ValueError(f"Key '{new_key}' already exists in the dictionary.") + + dictionary[new_key] = dictionary.pop(old_key) + + +def load_json(file: str) -> list[dict]: + """ + Loads and parses a JSON file. + + Args: + file (str): Path to the JSON file. + + Returns: + dict: Parsed data from the JSON file. + + Raises: + FileNotFoundError: If the file does not exist. + json.JSONDecodeError: If the file contains invalid JSON. + """ + try: + with open(file, "r") as fp: + data = json.load(fp) + return data + except FileNotFoundError as e: + raise FileNotFoundError(f"File not found: {file}") from e + except json.JSONDecodeError as e: + raise json.JSONDecodeError(f"Invalid JSON in file: {file}", e.doc, e.pos) + + +def write_json_dict(data: dict, keys_list: list[str], file:str) -> None: + """ + Write json from input object of dictionary + + Args: + data (dict): A object of type dictionary, though one key value should be a list of dictionaries (records) + keys_list (list[str]): A list of keys that are of type list[dict] (records). + file (str): The output file path + + Raises: + TypeError: If the keys provided with keys_list are not a list of dictionaries. + ValueError: If the JSON serialization fails. + """ + + if not isinstance(data, dict): + raise TypeError("The input data must be of type dict") + + for key in keys_list: + if not all(isinstance(item, dict) for item in data[key]): + raise TypeError(f"All elements in the list must be dictionaries for key {key}.") + + try: + # Serialize python object (data) to a JSON formatted string + json_object = json.dumps(data, indent=4) + except (TypeError, ValueError) as e: + raise ValueError(f"Failed to serialize the object to JSON: {e}") + + try: + # Write json string to the specified file + with open(file, "w") as outfile: + outfile.write(json_object) + print(f"JSON successfully written to {file}") + except IOError as e: + raise IOError(f"Failed to write to file {file}: {e}") + + +def write_json_records(data: list[dict], file:str) -> None: + """ + Writes json from input object of list[dict] + + Args: + data (list[dict]): A object of type list with elements as dictionaries + file (str): The output file path + + Raises: + TypeError: If the input is not a list of dictionaries. + ValueError: If the JSON serialization fails. + """ + if not isinstance(data, list): + raise TypeError("The input data must be of type list") + + if not all(isinstance(item, dict) for item in data): + raise TypeError("All elements in the list must be dictionaries.") + + try: + # Serialize python object (data) to a JSON formatted string + json_object = json.dumps(data, indent=4) + except (TypeError, ValueError) as e: + raise ValueError(f"Failed to serialize the object to JSON: {e}") + + try: + # Write json string to the specified file + with open(file, "w") as outfile: + outfile.write(json_object) + print(f"JSON successfully written to {file}") + except IOError as e: + raise IOError(f"Failed to write to file {file}: {e}") + + +def main(input_paths, output): + about = load_json(file=input_paths['about']) + agents = load_json(file=input_paths['agents']) + biomarkers = load_json(file=input_paths['biomarkers']) + contributions = load_json(file=input_paths['contributions']) + diseases = load_json(file=input_paths['diseases']) + documents = load_json(file=input_paths['documents']) + genes = load_json(file=input_paths['genes']) + indications = load_json(file=input_paths['indications']) + organizations = load_json(file=input_paths['organizations']) + propositions = load_json(file=input_paths['propositions']) + statements = load_json(file=input_paths['statements']) + therapies = load_json(file=input_paths['therapies']) + + # biomarkers; references genes.json + dereferenced_biomarkers = Dereference.list( + records=biomarkers, + referenced_key='genes', + referenced_records=genes, + key_always_present=False + ) + + # contributions; references agents.json + dereferenced_contributions = Dereference.integer( + records=contributions, + referenced_key='agent_id', + referenced_records=agents, + new_key_name='agent', + ) + + # documents; references organizations.json + dereferenced_documents = Dereference.integer( + records=documents, + referenced_key='organization_id', + referenced_records=organizations, + new_key_name='organization' + ) + + # indications; references documents.json + dereferenced_indications = Dereference.integer( + records=indications, + referenced_key='document_id', + referenced_records=dereferenced_documents, + new_key_name='document' + ) + + # propositions; references biomarkers.json, diseases.json, indications.json, and therapies.json + dereferenced_propositions = Dereference.list( + records=propositions, + referenced_key='biomarkers', + referenced_records=dereferenced_biomarkers, + key_always_present=True + ) + dereferenced_propositions = Dereference.integer( + records=dereferenced_propositions, + referenced_key='conditionQualifier_id', + referenced_records=diseases, + new_key_name='conditionQualifier' + ) + dereferenced_propositions = Dereference.integer( + records=dereferenced_propositions, + referenced_key='indication_id', + referenced_records=dereferenced_indications, + new_key_name='indication' + ) + dereferenced_propositions = Dereference.list( + records=dereferenced_propositions, + referenced_key='therapies', + referenced_records=therapies, + key_always_present=True + # This will not be True once we re-expand beyond sensitive relationships + ) + + # statements; references contributions.json, documents.json, and propositions.json + dereferenced_statements = Dereference.list( + records=statements, + referenced_key='contributions', + referenced_records=dereferenced_contributions, + key_always_present=True + ) + dereferenced_statements = Dereference.list( + records=dereferenced_statements, + referenced_key='reportedIn', + referenced_records=dereferenced_documents, + key_always_present=True + ) + dereferenced_statements = Dereference.integer( + records=dereferenced_statements, + referenced_key='proposition_id', + referenced_records=dereferenced_propositions, + new_key_name='proposition' + ) + + # Create final object + dereferenced = { + 'about': about, + 'content': dereferenced_statements + } + + # Write + write_json_dict( + data=dereferenced, + keys_list=['content'], + file=output + ) + + +if __name__ =="__main__": + arg_parser = argparse.ArgumentParser( + prog='dereference', + description='dereferences moalmanac db (currently in draft and development).' + ) + arg_parser.add_argument( + '--about', + help='json detailing db metadata', + default='referenced/about.json' + ), + arg_parser.add_argument( + '--agents', + help='json detailing agents', + default='referenced/agents.json' + ), + arg_parser.add_argument( + '--biomarkers', + help='json detailing db biomarkers', + default='referenced/biomarkers.json' + ), + arg_parser.add_argument( + '--contributions', + help='json detailing db contributions', + default='referenced/contributions.json' + ), + arg_parser.add_argument( + '--diseases', + help='json detailing db diseases', + default='referenced/diseases.json' + ), + arg_parser.add_argument( + '--documents', + help='json detailing db documents', + default='referenced/documents.json' + ) + arg_parser.add_argument( + '--genes', + help='json detailing db genes', + default='referenced/genes.json' + ), + arg_parser.add_argument( + '--indications', + help='json detailing db indications', + default='referenced/indications.json' + ), + arg_parser.add_argument( + '--organizations', + help='json detailing db organizations', + default='referenced/organizations.json' + ), + arg_parser.add_argument( + '--propositions', + help='json detailing db propositions', + default='referenced/propositions.json' + ), + arg_parser.add_argument( + '--statements', + help='json detailing db statements', + default='referenced/statements.json' + ), + arg_parser.add_argument( + '--therapies', + help='json detailing db therapies', + default='referenced/therapies.json' + ) + arg_parser.add_argument( + '--output', + help='Output json file', + default='moalmanac-draft.dereferenced.json' + ) + args = arg_parser.parse_args() + + input_data = { + 'about': args.about, + 'agents': args.agents, + 'biomarkers': args.biomarkers, + 'contributions': args.contributions, + 'diseases': args.diseases, + 'documents': args.documents, + 'genes': args.genes, + 'indications': args.indications, + 'organizations': args.organizations, + 'propositions': args.propositions, + 'statements': args.statements, + 'therapies': args.therapies + } + + main(input_paths=input_data, output=args.output) diff --git a/moalmanac-draft.dereferenced.json b/moalmanac-draft.dereferenced.json new file mode 100644 index 0000000..8bde051 --- /dev/null +++ b/moalmanac-draft.dereferenced.json @@ -0,0 +1,111290 @@ +{ + "about": { + "github": "https://github.com/vanallenlab/moalmanac-db", + "label": "Molecular Oncology Almanac", + "license": "GPL-2.0", + "release": "pre draft", + "url": "https://moalmanac.org", + "last_updated": "2025-01-10" + }, + "content": [ + { + "id": 0, + "type": "Statement", + "contributions": [ + { + "id": 0, + "type": "Contribution", + "agent": { + "id": 0, + "type": "Agent", + "subtype": "organization", + "label": "Van Allen lab", + "description": "Van Allen lab, Dana-Farber Cancer Institute" + }, + "description": "Initial access of FDA approvals", + "date": "2024-10-30" + } + ], + "reportedIn": [ + { + "id": 0, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Verzenio (abemaciclib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Eli and Lily Company. Verzenio (abemaciclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf. Revised March 2023. Accessed October 30, 2024.", + "company": "Eli and Lily Company.", + "drug_name_brand": "Verzenio", + "drug_name_generic": "abemaciclib", + "first_published": "", + "access_date": "2024-10-30", + "organization": { + "id": 0, + "label": "Food and Drug Administration", + "description": "Regulatory agency that approves drugs for use in the United States.", + "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", + "last_updated": "2025-01-10" + }, + "publication_date": "2023-03-03", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208716", + "application_number": 208716 + } + ], + "proposition": { + "id": 0, + "type": "VariantTherapeuticResponseProposition", + "predicate": "predictSensitivityTo", + "label": "", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. This indication is based on the monarchE (NCT03155997) clinical trial, which was a randomized (1:1), open-label, two cohort, multicenter study. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).", + "indication": { + "id": 0, + "document": { + "id": 0, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Verzenio (abemaciclib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Eli and Lily Company. Verzenio (abemaciclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf. Revised March 2023. Accessed October 30, 2024.", + "company": "Eli and Lily Company.", + "drug_name_brand": "Verzenio", + "drug_name_generic": "abemaciclib", + "first_published": "", + "access_date": "2024-10-30", + "organization": { + "id": 0, + "label": "Food and Drug Administration", + "description": "Regulatory agency that approves drugs for use in the United States.", + "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", + "last_updated": "2025-01-10" + }, + "publication_date": "2023-03-03", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208716", + "application_number": 208716 + }, + "indication": "Verzenio is a kinase inhibitor indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence.", + "initial_approval_date": "2023-03-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. This indication is based on the monarchE (NCT03155997) clinical trial, which was a randomized (1:1), open-label, two cohort, multicenter study. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "early breast cancer", + "raw_therapeutics": "Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor)" + }, + "biomarkers": [ + { + "id": 1, + "biomarker_type": "Protein expression", + "marker": "Estrogen receptor (ER)", + "unit": "status", + "equality": "=", + "value": "Positive", + "label": "ER positive", + "_present": true + }, + { + "id": 2, + "biomarker_type": "Protein expression", + "marker": "Human epidermal growth factor receptor 2 (HER2)", + "unit": "status", + "equality": "=", + "value": "Negative", + "label": "HER2-negative", + "_present": true + } + ], + "conditionQualifier": { + "id": 9, + "conceptType": "Disease", + "label": "Invasive Breast Carcinoma", + "extensions": [ + { + "name": "oncotree_code", + "value": "BRCA" + }, + { + "name": "oncotree_term", + "value": "Invasive Breast Carcinoma" + }, + { + "name": "solid_tumor", + "value": true + } + ] + }, + "therapies": [ + { + "id": 99, + "therapy_name": "Abemaciclib", + "therapy_strategy": "CDK4/6 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 119, + "therapy_name": "Tamoxifen", + "therapy_strategy": "Estrogen receptor inhibition", + "therapy_type": "Hormone therapy" + } + ], + "objectTherapeutic": "", + "subjectVariant": "" + }, + "direction": "supports", + "evidence": "Regulatory approval for use" + }, + { + "id": 1, + "type": "Statement", + "contributions": [ + { + "id": 0, + "type": "Contribution", + "agent": { + "id": 0, + "type": "Agent", + "subtype": "organization", + "label": "Van Allen lab", + "description": "Van Allen lab, Dana-Farber Cancer Institute" + }, + "description": "Initial access of FDA approvals", + "date": "2024-10-30" + } + ], + "reportedIn": [ + { + "id": 0, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Verzenio (abemaciclib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Eli and Lily Company. Verzenio (abemaciclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf. Revised March 2023. Accessed October 30, 2024.", + "company": "Eli and Lily Company.", + "drug_name_brand": "Verzenio", + "drug_name_generic": "abemaciclib", + "first_published": "", + "access_date": "2024-10-30", + "organization": { + "id": 0, + "label": "Food and Drug Administration", + "description": "Regulatory agency that approves drugs for use in the United States.", + "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", + "last_updated": "2025-01-10" + }, + "publication_date": "2023-03-03", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208716", + "application_number": 208716 + } + ], + "proposition": { + "id": 1, + "type": "VariantTherapeuticResponseProposition", + "predicate": "predictSensitivityTo", + "label": "", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. This indication is based on the monarchE (NCT03155997) clinical trial, which was a randomized (1:1), open-label, two cohort, multicenter study. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).", + "indication": { + "id": 0, + "document": { + "id": 0, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Verzenio (abemaciclib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Eli and Lily Company. Verzenio (abemaciclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf. Revised March 2023. Accessed October 30, 2024.", + "company": "Eli and Lily Company.", + "drug_name_brand": "Verzenio", + "drug_name_generic": "abemaciclib", + "first_published": "", + "access_date": "2024-10-30", + "organization": { + "id": 0, + "label": "Food and Drug Administration", + "description": "Regulatory agency that approves drugs for use in the United States.", + "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", + "last_updated": "2025-01-10" + }, + "publication_date": "2023-03-03", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208716", + "application_number": 208716 + }, + "indication": "Verzenio is a kinase inhibitor indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence.", + "initial_approval_date": "2023-03-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. This indication is based on the monarchE (NCT03155997) clinical trial, which was a randomized (1:1), open-label, two cohort, multicenter study. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "early breast cancer", + "raw_therapeutics": "Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor)" + }, + "biomarkers": [ + { + "id": 2, + "biomarker_type": "Protein expression", + "marker": "Human epidermal growth factor receptor 2 (HER2)", + "unit": "status", + "equality": "=", + "value": "Negative", + "label": "HER2-negative", + "_present": true + }, + { + "id": 3, + "biomarker_type": "Protein expression", + "marker": "Progesterone receptor (PR)", + "unit": "status", + "equality": "=", + "value": "Positive", + "label": "PR positive", + "_present": true + } + ], + "conditionQualifier": { + "id": 9, + "conceptType": "Disease", + "label": "Invasive Breast Carcinoma", + "extensions": [ + { + "name": "oncotree_code", + "value": "BRCA" + }, + { + "name": "oncotree_term", + "value": "Invasive Breast Carcinoma" + }, + { + "name": "solid_tumor", + "value": true + } + ] + }, + "therapies": [ + { + "id": 99, + "therapy_name": "Abemaciclib", + "therapy_strategy": "CDK4/6 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 119, + "therapy_name": "Tamoxifen", + "therapy_strategy": "Estrogen receptor inhibition", + "therapy_type": "Hormone therapy" + } + ], + "objectTherapeutic": "", + "subjectVariant": "" + }, + "direction": "supports", + "evidence": "Regulatory approval for use" + }, + { + "id": 2, + "type": "Statement", + "contributions": [ + { + "id": 0, + "type": "Contribution", + "agent": { + "id": 0, + "type": "Agent", + "subtype": "organization", + "label": "Van Allen lab", + "description": "Van Allen lab, Dana-Farber Cancer Institute" + }, + "description": "Initial access of FDA approvals", + "date": "2024-10-30" + } + ], + "reportedIn": [ + { + "id": 0, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Verzenio (abemaciclib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Eli and Lily Company. Verzenio (abemaciclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf. Revised March 2023. 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U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216340Orig1s000Corrected_lbl.pdf. Revised December 2022. Accessed October 30, 2024.", + "company": "Mirati Therapeutics, Inc.", + "drug_name_brand": "Krazati", + "drug_name_generic": "adagrasib", + "first_published": "2022-12-12", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-12-12", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216340Orig1s000Corrected_lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=216340", + "application_number": 216340 + }, + { + "id": 3, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Kadcyla (ado-trastuzumab emtansine) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Genentech, Inc. Kadcyla (ado-trastuzumab emtansine) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf. Revised January 2022. Accessed October 30, 2024.", + "company": "Genentech, Inc.", + "drug_name_brand": "Kadcyla", + "drug_name_generic": "ado-trastuzumab emtansine", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-02-02", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125427", + "application_number": 125427 + }, + { + "id": 4, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Gilotrif (afatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Boehringer Ingelheim Pharmaceuticals, Inc. Gilotrif (afatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201292s017lbl.pdf. Revised April 2022. Accessed October 30, 2024.", + "company": "Boehringer Ingelheim Pharmaceuticals, Inc.", + "drug_name_brand": "Gilotrif", + "drug_name_generic": "afatinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-04-07", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201292s017lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201292", + "application_number": 201292 + }, + { + "id": 5, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Alecensa (alectinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Genentech, Inc. Alecensa (alectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208434s015lbl.pdf. Revised February 2023. Accessed October 30, 2024.", + "company": "Genentech, Inc.", + "drug_name_brand": "Alecensa", + "drug_name_generic": "alectinib", + "first_published": "2015-12-11", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-04-18", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208434s015lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208434", + "application_number": 208434 + }, + { + "id": 6, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Piqray (alpelisib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Novartis Pharmaceuticals Corporation. Piqray (alpelisib) [package insert]. 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Accessed October 30, 2024.", + "company": "Seagen Inc.", + "drug_name_brand": "Adcetris", + "drug_name_generic": "brentuximab vedotin", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-06-14", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125388s107lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125388", + "application_number": 125388 + }, + { + "id": 16, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Alunbrig (brigatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Takeda Pharmaceuticals America, Inc. Alunbrig (brigatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208772s013lbl.pdf. Revised February 2022. Accessed October 30, 2024.", + "company": "Takeda Pharmaceuticals America, Inc.", + "drug_name_brand": "Alunbrig", + "drug_name_generic": "brigatinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-02-28", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208772s013lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208772", + "application_number": 208772 + }, + { + "id": 17, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Xeloda (capecitabine) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Genentech, Inc. Xeloda (capecitabine) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf. Revised December 2022. Accessed October 30, 2024.", + "company": "Genentech, Inc.", + "drug_name_brand": "Xeloda", + "drug_name_generic": "capecitabine", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-12-14", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020896", + "application_number": 20896 + }, + { + "id": 18, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Truqap (capivasertib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "AstraZeneca Pharmaceuticals, LP. Truqap (capivasertib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218197s000lbl.pdf. Revised November 2023. Accessed October 30, 2024.", + "company": "AstraZeneca Pharmaceuticals, LP.", + "drug_name_brand": "Truqap", + "drug_name_generic": "capivasertib", + "first_published": "2023-11-16", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-11-16", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218197s000lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218197", + "application_number": 218197 + }, + { + "id": 19, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Tabrecta (capmatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Novartis Pharmaceuticals Corporation. Tabrecta (capmatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213591s011lbl.pdf. Revised March 2024. Accessed October 30, 2024.", + "company": "Novartis Pharmaceuticals Corporation.", + "drug_name_brand": "Tabrecta", + "drug_name_generic": "capmatinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-03-14", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213591s011lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213591", + "application_number": 213591 + }, + { + "id": 20, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Libtayo (cemiplimab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Regeneron Pharmaceuticals, Inc. Libtayo (cemiplimab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761097s023lbl.pdf. Revised April 2024. Accessed October 30, 2024.", + "company": "Regeneron Pharmaceuticals, Inc.", + "drug_name_brand": "Libtayo", + "drug_name_generic": "cemiplimab", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-04-05", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761097s023lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761097", + "application_number": 761097 + }, + { + "id": 21, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Zykadia (ceritinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Novartis Pharmaceuticals Corporation. Zykadia (ceritinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211225s004lbl.pdf. Revised October 2021. Accessed October 30, 2024.", + "company": "Novartis Pharmaceuticals Corporation.", + "drug_name_brand": "Zykadia", + "drug_name_generic": "ceritinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2021-10-07", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211225s004lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211225", + "application_number": 211225 + }, + { + "id": 22, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Erbitux (cetuximab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "ImClone LLC. Erbitux (cetuximab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf. Revised September 2021. Accessed October 30, 2024.", + "company": "ImClone LLC.", + "drug_name_brand": "Erbitux", + "drug_name_generic": "cetuximab", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2021-09-24", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125084", + "application_number": 125084 + }, + { + "id": 23, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Cotellic (cobimetinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Genentech USA, Inc. Cotellic (cobimetinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206192s006lbl.pdf. Revised May 2023. Accessed October 30, 2024.", + "company": "Genentech USA, Inc.", + "drug_name_brand": "Cotellic", + "drug_name_generic": "cobimetinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-05-31", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206192s006lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206192", + "application_number": 206192 + }, + { + "id": 24, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Xalkori (crizotinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Pfizer, Inc. Xalkori (crizotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202570s036lbl.pdf. Revised September 2023. Accessed October 30, 2024.", + "company": "Pfizer, Inc.", + "drug_name_brand": "Xalkori", + "drug_name_generic": "crizotinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-09-07", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202570s036lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202570", + "application_number": 202570 + }, + { + "id": 25, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Tafinlar (dabrafenib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Novartis Pharmaceuticals Corporation. Tafinlar (dabrafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202806s030lbl.pdf. Revised March 2024. Accessed October 30, 2024.", + "company": "Novartis Pharmaceuticals Corporation.", + "drug_name_brand": "Tafinlar", + "drug_name_generic": "dabrafenib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-03-29", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202806s030lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202806", + "application_number": 202806 + }, + { + "id": 26, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Vizimpro (dacomitinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Pfizer, Inc. Vizimpro (dacomitinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211288s003lbl.pdf. Revised December 2020. Accessed October 30, 2024.", + "company": "Pfizer, Inc.", + "drug_name_brand": "Vizimpro", + "drug_name_generic": "dacomitinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2020-12-18", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211288s003lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211288", + "application_number": 211288 + }, + { + "id": 27, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Sprycel (dasatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Bristol-Myers Squibb Company. Sprycel (dasatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021986s027lbl.pdf. Revised February 2023. Accessed October 30, 2024.", + "company": "Bristol-Myers Squibb Company.", + "drug_name_brand": "Sprycel", + "drug_name_generic": "dasatinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-02-08", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021986s027lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021986", + "application_number": 21986 + }, + { + "id": 28, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Jemperli (dostarlimab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "GlaxoSmithKline LLC. Jemperli (dostarlimab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761174s010lbl.pdf. Revised March 2024. Accessed October 30, 2024.", + "company": "GlaxoSmithKline LLC.", + "drug_name_brand": "Jemperli", + "drug_name_generic": "dostarlimab", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-03-06", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761174s010lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761174", + "application_number": 761174 + }, + { + "id": 29, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Imfinzi (durvalumab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "AstraZeneca UK Limited. Imfinzi (durvalumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s043lbledt.pdf. Revised August 2024. Accessed October 30, 2024.", + "company": "AstraZeneca UK Limited.", + "drug_name_brand": "Imfinzi", + "drug_name_generic": "durvalumab", + "first_published": "2017-05-01", + "access_date": "2025-01-17", + "organization_id": 0, + "publication_date": "2024-08-15", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s043lbledt.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761069", + "application_number": 761069 + }, + { + "id": 30, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Orserdu (elacestrant) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Stemline Therapeutics, Inc. Orserdu (elacestrant) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s001lbl.pdf. Revised May 2023. Accessed October 30, 2024.", + "company": "Stemline Therapeutics, Inc.", + "drug_name_brand": "Orserdu", + "drug_name_generic": "elacestrant", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-11-09", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s001lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217639", + "application_number": 217639 + }, + { + "id": 31, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Idhifa (enasidenib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Celgene Corporation. Idhifa (enasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209606s006lbl.pdf. Revised December 2023. Accessed October 30, 2024.", + "company": "Celgene Corporation.", + "drug_name_brand": "Idhifa", + "drug_name_generic": "enasidenib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-12-21", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209606s006lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209606", + "application_number": 209606 + }, + { + "id": 32, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Braftovi (encorafenib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Array BioPharma, Inc. Braftovi (encorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s017lbl.pdf. Revised December 2024. Accessed January 10, 2025.", + "company": "Array BioPharma, Inc.", + "drug_name_brand": "Braftovi", + "drug_name_generic": "encorafenib", + "first_published": "2018-06-27", + "access_date": "2025-01-10", + "organization_id": 0, + "publication_date": "2024-12-20", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s017lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210496", + "application_number": 210496 + }, + { + "id": 33, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Rozlytrek (entrectinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Genentech, Inc. Rozlytrek (entrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212725s011lbl.pdf. Revised January 2024. Accessed October 30, 2024.", + "company": "Genentech, Inc.", + "drug_name_brand": "Rozlytrek", + "drug_name_generic": "entrectinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-01-26", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212725s011lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212725", + "application_number": 212725 + }, + { + "id": 34, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Balversa (erdafitinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Janssen Products, LP. Balversa (erdafitinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf. Revised January 2024. Accessed October 30, 2024.", + "company": "Janssen Products, LP.", + "drug_name_brand": "Balversa", + "drug_name_generic": "erdafitinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-01-19", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212018", + "application_number": 212018 + }, + { + "id": 35, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Tarceva (erlotinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "OSI Pharmaceuticals, LLC. Tarceva (erlotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf. Revised October 2016. Accessed October 30, 2024.", + "company": "OSI Pharmaceuticals, LLC.", + "drug_name_brand": "Tarceva", + "drug_name_generic": "erlotinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2016-10-18", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021743", + "application_number": 21743 + }, + { + "id": 36, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Afinitor (everolimus) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Novartis Pharmaceuticals Corporation. Afinitor (everolimus) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203985s023,022334s051lbl.pdf. Revised February 2022. Accessed October 30, 2024.", + "company": "Novartis Pharmaceuticals Corporation.", + "drug_name_brand": "Afinitor", + "drug_name_generic": "everolimus", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-02-01", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203985s023,022334s051lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022334", + "application_number": 22334 + }, + { + "id": 37, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Faslodex (fulvestrant) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "AstraZeneca UK Limited. Faslodex (fulvestrant) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021344s044lbl.pdf. Revised January 2021. Accessed October 30, 2024.", + "company": "AstraZeneca UK Limited.", + "drug_name_brand": "Faslodex", + "drug_name_generic": "fulvestrant", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2021-01-19", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021344s044lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021344", + "application_number": 21344 + }, + { + "id": 38, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Lytgobi (futibatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Taiho Pharmaceutical Co., Ltd. Lytgobi (futibatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214801s002lbl.pdf. Revised April 2024. Accessed October 30, 2024.", + "company": "Taiho Pharmaceutical Co., Ltd.", + "drug_name_brand": "Lytgobi", + "drug_name_generic": "futibatinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-04-17", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214801s002lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214801", + "application_number": 214801 + }, + { + "id": 39, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Iressa (gefitinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "AstraZeneca Pharmaceuticals, LP. Iressa (gefitinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206995s004lbl.pdf. Revised May 2021. Accessed October 30, 2024.", + "company": "AstraZeneca Pharmaceuticals, LP.", + "drug_name_brand": "Iressa", + "drug_name_generic": "gefitinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2021-05-05", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206995s004lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206995", + "application_number": 206995 + }, + { + "id": 40, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Mylotarg (gemtuzumab ozogamicin) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Wyeth Pharmaceuticals LLC. Mylotarg (gemtuzumab ozogamicin) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761060s004lbl.pdf. Revised June 2022. Accessed October 30, 2024.", + "company": "Wyeth Pharmaceuticals LLC.", + "drug_name_brand": "Mylotarg", + "drug_name_generic": "gemtuzumab ozogamicin", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2020-06-16", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761060s004lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761060", + "application_number": 761060 + }, + { + "id": 41, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Xospata (gilteritinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Astellas Pharma US, Inc. Xospata (gilteritinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211349s003lbl.pdf. Revised January 2022. Accessed October 30, 2024.", + "company": "Astellas Pharma US, Inc.", + "drug_name_brand": "Xospata", + "drug_name_generic": "gilteritinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-01-12", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211349s003lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211349", + "application_number": 211349 + }, + { + "id": 42, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Gleevec (imatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Novartis Pharmaceuticals Corporation. Gleevec (imatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021588s062lbl.pdf. Revised August 2022. Accessed October 30, 2024.", + "company": "Novartis Pharmaceuticals Corporation.", + "drug_name_brand": "Gleevec", + "drug_name_generic": "imatinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-03-01", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021588s062lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021588", + "application_number": 21588 + }, + { + "id": 43, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Truseltiq (infigratinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "QED Therapeutics, Inc. Truseltiq (infigratinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214622s000lbl.pdf. Revised May 2021. Accessed October 30, 2024.", + "company": "QED Therapeutics, Inc.", + "drug_name_brand": "Truseltiq", + "drug_name_generic": "infigratinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2021-05-28", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214622s000lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214622", + "application_number": 214622 + }, + { + "id": 44, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Besponsa (inotuzumab ozogamicin) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Wyeth Pharmaceuticals LLC. Besponsa (inotuzumab ozogamicin) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761040s003lbl.pdf. Revised March 2024. Accessed October 30, 2024.", + "company": "Wyeth Pharmaceuticals LLC.", + "drug_name_brand": "Besponsa", + "drug_name_generic": "inotuzumab ozogamicin", + "first_published": "2017-08-17", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-03-06", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761040s003lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761040", + "application_number": 761040 + }, + { + "id": 45, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Yervoy (ipilimumab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Bristol-Myers Squibb Company. Yervoy (ipilimumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125377s129lbl.pdf. Revised February 2023. Accessed October 30, 2024.", + "company": "Bristol-Myers Squibb Company.", + "drug_name_brand": "Yervoy", + "drug_name_generic": "ipilimumab", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-02-15", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125377s129lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125377", + "application_number": 125377 + }, + { + "id": 46, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Tibsovo (ivosidenib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Agios Pharmaceuticals, Inc. Tibsovo (ivosidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf. Revised October 2023. Accessed October 30, 2024.", + "company": "Agios Pharmaceuticals, Inc.", + "drug_name_brand": "Tibsovo", + "drug_name_generic": "ivosidenib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-10-24", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211192", + "application_number": 211192 + }, + { + "id": 47, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Tykerb (lapatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Novartis Pharmaceuticals Corporation. Tykerb (lapatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022059s031lbl.pdf. Revised March 2022. Accessed October 30, 2024.", + "company": "Novartis Pharmaceuticals Corporation.", + "drug_name_brand": "Tykerb", + "drug_name_generic": "lapatinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-03-27", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022059s031lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022059", + "application_number": 22059 + }, + { + "id": 48, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Vitrakvi (larotrectinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Loxo Oncology, Inc. Vitrakvi (larotrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210861s010lbl.pdf. Revised November 2023. Accessed October 30, 2024.", + "company": "Loxo Oncology, Inc.", + "drug_name_brand": "Vitrakvi", + "drug_name_generic": "larotrectinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-11-03", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210861s010lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210861", + "application_number": 210861 + }, + { + "id": 49, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Revlimid (lenalidomide) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Bristol-Myers Squibb Company. Revlimid (lenalidomide) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021880s067lbl.pdf. Revised March 2023. Accessed October 30, 2024.", + "company": "Bristol-Myers Squibb Company.", + "drug_name_brand": "Revlimid", + "drug_name_generic": "lenalidomide", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-03-24", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021880s067lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021880", + "application_number": 21880 + }, + { + "id": 50, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Lorbrena (lorlatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Pfizer, Inc. Lorbrena (lorlatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s004lbl.pdf. Revised March 2021. Accessed October 30, 2024.", + "company": "Pfizer, Inc.", + "drug_name_brand": "Lorbrena", + "drug_name_generic": "lorlatinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2021-03-03", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s004lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210868", + "application_number": 210868 + }, + { + "id": 51, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Margenza (margetuximab-cmkb) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "MacroGenics, Inc. Margenza (margetuximab-cmkb) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761150s005lbl.pdf. Revised May 2023. Accessed October 30, 2024.", + "company": "MacroGenics, Inc.", + "drug_name_brand": "Margenza", + "drug_name_generic": "margetuximab-cmkb", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-05-25", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761150s005lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761150", + "application_number": 761150 + }, + { + "id": 52, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Rydapt (midostaurin) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Novartis Pharmaceuticals Corporation. Rydapt (midostaurin) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207997s010lbl.pdf. Revised May 2023. Accessed October 30, 2024.", + "company": "Novartis Pharmaceuticals Corporation.", + "drug_name_brand": "Rydapt", + "drug_name_generic": "midostaurin", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-05-22", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207997s010lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207997", + "application_number": 207997 + }, + { + "id": 53, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Exkivity (mobocertinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Takeda Pharmaceuticals America, Inc. Exkivity (mobocertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215310s003lbl.pdf. Revised September 2023. Accessed October 30, 2024.", + "company": "Takeda Pharmaceuticals America, Inc.", + "drug_name_brand": "Exkivity", + "drug_name_generic": "mobocertinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-09-15", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215310s003lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process", + "application_number": 215310 + }, + { + "id": 54, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Nerlynx (neratinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Puma Biotechnology, Inc. Nerlynx (neratinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208051s009lbl.pdf. Revised June 2021. Accessed October 30, 2024.", + "company": "Puma Biotechnology, Inc.", + "drug_name_brand": "Nerlynx", + "drug_name_generic": "neratinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2021-06-28", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208051s009lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208051", + "application_number": 208051 + }, + { + "id": 55, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Tasigna (nilotinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Novartis Pharmaceuticals Corporation. Tasigna (nilotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068s041lbl.pdf. Revised February 2024. Accessed October 30, 2024.", + "company": "Novartis Pharmaceuticals Corporation.", + "drug_name_brand": "Tasigna", + "drug_name_generic": "nilotinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-02-29", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068s041lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022068", + "application_number": 22068 + }, + { + "id": 56, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Zejula (niraparib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "GlaxoSmithKline. Zejula (niraparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214876s000lbl.pdf. Revised April 2023. Accessed October 30, 2024.", + "company": "GlaxoSmithKline.", + "drug_name_brand": "Zejula", + "drug_name_generic": "niraparib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-04-26", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214876s000lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214876", + "application_number": 214876 + }, + { + "id": 57, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Opdivo (nivolumab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125527s000lbl.pdf. Revised October 2024. Accessed October 30, 2024.", + "company": "Bristol-Myers Squibb Company.", + "drug_name_brand": "Opdivo", + "drug_name_generic": "nivolumab", + "first_published": "2014-12-22", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-10-03", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s127lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554", + "application_number": 125554 + }, + { + "id": 58, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Lynparza (olaparib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "AstraZeneca Pharmaceuticals, LP. Lynparza (olaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf. Revised November 2023. Accessed October 30, 2024.", + "company": "AstraZeneca Pharmaceuticals, LP.", + "drug_name_brand": "Lynparza", + "drug_name_generic": "olaparib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-11-06", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208558", + "application_number": 208558 + }, + { + "id": 59, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Rezlidhia (olutasidenib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Metrics Contract Services. Rezlidhia (olutasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215814s000lbl.pdf. Revised December 2022. Accessed October 30, 2024.", + "company": "Metrics Contract Services.", + "drug_name_brand": "Rezlidhia", + "drug_name_generic": "olutasidenib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-12-01", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215814s000lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215814", + "application_number": 215814 + }, + { + "id": 60, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Tagrisso (osimertinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "AstraZeneca Pharmaceuticals, LP. Tagrisso (osimertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf. Revised September 2024. Accessed October 30, 2024.", + "company": "AstraZeneca Pharmaceuticals, LP.", + "drug_name_brand": "Tagrisso", + "drug_name_generic": "osimertinib", + "first_published": "2015-11-13", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-09-25", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208065", + "application_number": 208065 + }, + { + "id": 61, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Ibrance (palbociclib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Pfizer, Inc. Ibrance (palbociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207103s017s018lbl.pdf. Revised September 2023. Accessed October 30, 2024.", + "company": "Pfizer, Inc.", + "drug_name_brand": "Ibrance", + "drug_name_generic": "palbociclib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-09-06", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207103s017s018lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207103", + "application_number": 207103 + }, + { + "id": 62, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Vectibix (panitumumab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Amgen, Inc. Vectibix (panitumumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125147s210lbl.pdf. Revised April 2021. Accessed October 30, 2024.", + "company": "Amgen, Inc.", + "drug_name_brand": "Vectibix", + "drug_name_generic": "panitumumab", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2021-08-25", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125147s210lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125147", + "application_number": 125147 + }, + { + "id": 63, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Keytruda (pembrolizumab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125514s154lbl.pdf. Revised June 2024. Accessed October 30, 2024.", + "company": "Merck Sharp & Dohme Corp.", + "drug_name_brand": "Keytruda", + "drug_name_generic": "pembrolizumab", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-06-17", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125514s154lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514", + "application_number": 125514 + }, + { + "id": 64, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Pemazyre (pemigatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Incyte Corporation. Pemazyre (pemigatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf. Revised August 2022. Accessed October 30, 2024.", + "company": "Incyte Corporation.", + "drug_name_brand": "Pemazyre", + "drug_name_generic": "pemigatinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2020-04-17", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213736", + "application_number": 213736 + }, + { + "id": 65, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Perjeta (pertuzumab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Genentech, Inc. Perjeta (pertuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf. Revised January 2020. Accessed October 30, 2024.", + "company": "Genentech, Inc.", + "drug_name_brand": "Perjeta", + "drug_name_generic": "pertuzumab", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2020-01-16", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125409", + "application_number": 125409 + }, + { + "id": 66, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Phesgo (pertuzumab and trastuzumab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Genentech, Inc. Phesgo (pertuzumab and trastuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf. Revised June 2020. Accessed October 30, 2024.", + "company": "Genentech, Inc.", + "drug_name_brand": "Phesgo", + "drug_name_generic": "pertuzumab and trastuzumab", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2020-06-29", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761170", + "application_number": 761170 + }, + { + "id": 67, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Iclusig (ponatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Takeda Pharmaceuticals America, Inc. Iclusig (ponatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf. Revised March 2024. Accessed October 30, 2024.", + "company": "Takeda Pharmaceuticals America, Inc.", + "drug_name_brand": "Iclusig", + "drug_name_generic": "ponatinib", + "first_published": "2012-12-14", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-03-19", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203469", + "application_number": 203469 + }, + { + "id": 68, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Gavreto (pralsetinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Blueprint Medicines Corporation. Gavreto (pralsetinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213721s015lbl.pdf. Revised March 2024. Accessed October 30, 2024.", + "company": "Blueprint Medicines Corporation.", + "drug_name_brand": "Gavreto", + "drug_name_generic": "pralsetinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-03-22", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213721s015lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213721", + "application_number": 213721 + }, + { + "id": 69, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Cyramza (ramucirumab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Eli and Lily Company. Cyramza (ramucirumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125477s042lbl.pdf. Revised March 2022. Accessed October 30, 2024.", + "company": "Eli and Lily Company.", + "drug_name_brand": "Cyramza", + "drug_name_generic": "ramucirumab", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-03-22", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125477s042lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125477", + "application_number": 125477 + }, + { + "id": 70, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Augtyro (repotrectinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Bristol-Myers Squibb. Augtyro (repotrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218213s001lbl.pdf. Revised June 2024. Accessed October 30, 2024.", + "company": "Bristol-Myers Squibb.", + "drug_name_brand": "Augtyro", + "drug_name_generic": "repotrectinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-06-13", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218213s001lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218213", + "application_number": 218213 + }, + { + "id": 71, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Kisqali (ribociclib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Novartis Pharmaceuticals Corporation. Kisqali (ribociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf. Revised September 2024. Accessed October 30, 2024.", + "company": "Novartis Pharmaceuticals Corporation.", + "drug_name_brand": "Kisqali", + "drug_name_generic": "ribociclib", + "first_published": "2017-03-13", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-09-17", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209092", + "application_number": 209092 + }, + { + "id": 72, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Rituxan (rituximab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Genentech, Inc. Rituxan (rituximab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5467lbl.pdf. Revised December 2021. Accessed October 30, 2024.", + "company": "Genentech, Inc.", + "drug_name_brand": "Rituxan", + "drug_name_generic": "rituximab", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2021-12-17", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5467lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103705", + "application_number": 103705 + }, + { + "id": 73, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Rubraca (rucaparib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Clovis Oncology, Inc. Rubraca (rucaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209115s013lbl.pdf. Revised December 2022. Accessed October 30, 2024.", + "company": "Clovis Oncology, Inc.", + "drug_name_brand": "Rubraca", + "drug_name_generic": "rucaparib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-12-21", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209115s013lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209115", + "application_number": 209115 + }, + { + "id": 74, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Trodelvy (sacituzumab govitecan) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Gilead Sciences, Inc. Trodelvy (sacituzumab govitecan) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761115s035lbl.pdf. Revised February 2023. Accessed October 30, 2024.", + "company": "Gilead Sciences, Inc.", + "drug_name_brand": "Trodelvy", + "drug_name_generic": "sacituzumab govitecan", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-02-03", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761115s035lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761115", + "application_number": 761115 + }, + { + "id": 75, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Retevmo (selpercatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Eli Lilly and Company. Retevmo (selpercatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s011s013lbl.pdf. Revised September 2024. Accessed October 30, 2024.", + "company": "Eli Lilly and Company.", + "drug_name_brand": "Retevmo", + "drug_name_generic": "selpercatinib", + "first_published": "2020-05-08", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-09-27", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s011s013lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213246", + "application_number": 213246 + }, + { + "id": 76, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Lumakras (sotorasib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Amgen, Inc. Lumakras (sotorasib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s004lbl.pdf. Revised April 2023. Accessed October 30, 2024.", + "company": "Amgen, Inc.", + "drug_name_brand": "Lumakras", + "drug_name_generic": "sotorasib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-04-23", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s004lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214665", + "application_number": 214665 + }, + { + "id": 77, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Talzenna (talazoparib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Pfizer, Inc. Talzenna (talazoparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211651s012lbl.pdf. Revised February 2024. Accessed October 30, 2024.", + "company": "Pfizer, Inc.", + "drug_name_brand": "Talzenna", + "drug_name_generic": "talazoparib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-02-06", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211651s012lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211651", + "application_number": 211651 + }, + { + "id": 78, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Tazverik (tazemetostat) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Epizyme, Inc. Tazverik (tazemetostat) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211723s004lbl.pdf. Revised November 2023. Accessed October 30, 2024.", + "company": "Epizyme, Inc.", + "drug_name_brand": "Tazverik", + "drug_name_generic": "tazemetostat", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-11-16", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211723s004lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211723", + "application_number": 211723 + }, + { + "id": 79, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Tepmetko (tepotinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "EMD Serono, Inc. Tepmetko (tepotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214096s003lbl.pdf. Revised February 2023. Accessed October 30, 2024.", + "company": "EMD Serono, Inc.", + "drug_name_brand": "Tepmetko", + "drug_name_generic": "tepotinib", + "first_published": "2021-02-03", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-02-15", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214096s003lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214096", + "application_number": 214096 + }, + { + "id": 80, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Mekinist (trametinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Novartis Pharmaceuticals Corporation. Mekinist (trametinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217513s003lbl.pdf. Revised March 2024. Accessed October 30, 2024.", + "company": "Novartis Pharmaceuticals Corporation.", + "drug_name_brand": "Mekinist", + "drug_name_generic": "trametinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-03-29", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217513s003lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217513", + "application_number": 217513 + }, + { + "id": 81, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Herceptin (trastuzumab) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Genentech, Inc. Herceptin (trastuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103792s5354lbl.pdf. Revised June 2024. Accessed October 30, 2024.", + "company": "Genentech, Inc.", + "drug_name_brand": "Herceptin", + "drug_name_generic": "trastuzumab", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-06-18", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103792s5354lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103792", + "application_number": 103792 + }, + { + "id": 82, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Enhertu (trastuzumab deruxtecan) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Daiichi Sankyo, Inc. Enhertu (trastuzumab deruxtecan) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761139s028lbl.pdf. Revised April 2024. Accessed October 30, 2024.", + "company": "Daiichi Sankyo, Inc.", + "drug_name_brand": "Enhertu", + "drug_name_generic": "trastuzumab deruxtecan", + "first_published": "2019-12-20", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2024-04-05", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761139s028lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139", + "application_number": 761139 + }, + { + "id": 83, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Imjudo (tremelimumab-actl) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "AstraZeneca AB. Imjudo (tremelimumab-actl) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf. Revised November 2022. Accessed October 30, 2024.", + "company": "AstraZeneca AB.", + "drug_name_brand": "Imjudo", + "drug_name_generic": "tremelimumab-actl", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2022-11-10", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761270", + "application_number": 761270 + }, + { + "id": 84, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Tukysa (tucatinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Seagen Inc. Tukysa (tucatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213411s004lbl.pdf. Revised January 2023. Accessed October 30, 2024.", + "company": "Seagen Inc.", + "drug_name_brand": "Tukysa", + "drug_name_generic": "tucatinib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2023-01-19", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213411s004lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213411", + "application_number": 213411 + }, + { + "id": 85, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Zelboraf (vemurafenib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Genentech, Inc. Zelboraf (vemurafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202429s019lbl.pdf. Revised May 2020. Accessed October 30, 2024.", + "company": "Genentech, Inc.", + "drug_name_brand": "Zelboraf", + "drug_name_generic": "vemurafenib", + "first_published": "", + "access_date": "2024-10-30", + "organization_id": 0, + "publication_date": "2020-05-18", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202429s019lbl.pdf", + "url_drug": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202429", + "application_number": 202429 + }, + { + "id": 86, + "type": "Document", + "subtype": "Regulatory approval", + "label": "Lazcluze (lazertinib) [package insert]. U.S. FDA.", + "alternativeLabels": [], + "citation": "Janssen Biotech, Inc. Lazcluze (lazertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219008s000lbledt.pdf. Revised August 2024. 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recurrence.", + "initial_approval_date": "2023-03-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. This indication is based on the monarchE (NCT03155997) clinical trial, which was a randomized (1:1), open-label, two cohort, multicenter study. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "early breast cancer", + "raw_therapeutics": "Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor)" + }, + { + "id": 1, + "document_id": 0, + "indication": "Verzenio is a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.", + "initial_approval_date": "2018-08-17", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208716s001lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer. This indication is based on the MONARCH 3 (NCT02246621) clinical trial, which was a randomized (2:1), double-blinded, placebo-controlled, multicenter study. A total of 493 patients were randomized to receive 150 mg abemaciclib or placebo orally twice daily, plus physician's choice of letrozole (80% of patients) or anastrozole (20%).", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Verzenio (abemaciclib) in combination with an aromatase inhibitor" + }, + { + "id": 2, + "document_id": 0, + "indication": "Verzenio is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.", + "initial_approval_date": "2017-09-28", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716Orig1s000lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Verzenio (abemaciclib) in combination with fulvestrant" + }, + { + "id": 3, + "document_id": 0, + "indication": "Verzenio is a kinase inhibitor indicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. ", + "initial_approval_date": "2017-09-28", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716Orig1s000lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Verzenio (abemaciclib)" + }, + { + "id": 4, + "document_id": 1, + "indication": "AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA.", + "initial_approval_date": "2018-08-11", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216793s000lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to Akeega (abiraterone acetate with niraparib) in combination with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved test for Akeega.", + "raw_biomarkers": "deleterious or suspected deleterious BRCA-mutated (BRCAm)", + "raw_cancer_type": "metastatic castration-resistant prostate cancer", + "raw_therapeutics": "Akeega (abiraterone acetate and niraparib) in combination with prednisone" + }, + { + "id": 5, + "document_id": 2, + "indication": "KRAZATI is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s)", + "initial_approval_date": "2022-12-12", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216340Orig1s000Corrected_lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to adagrasib for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA approved test, who have received at least one prior systemic therapy. The product label notes that this indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR), and that continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).", + "raw_biomarkers": "KRAS G12C", + "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer", + "raw_therapeutics": "Krazati (adagrasib)", + "date_regular_approval": "", + "date_accelerated_approval": "2022-12-20" + }, + { + "id": 6, + "document_id": 3, + "indication": "KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease; or developed disease recurrence during or within six months of completing adjuvant therapy. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA.", + "initial_approval_date": "2013-02-22", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ado-trastuzumab emtansine", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "metastatic breast cancer", + "raw_therapeutics": "Kadcyla (ado-trastuzumab emtansine)" + }, + { + "id": 7, + "document_id": 3, + "indication": "KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA.", + "initial_approval_date": "2019-05-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125427s105lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ado-trastuzumab emtansine for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for ado-trastuzumab emtansine.", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "early breast cancer", + "raw_therapeutics": "Kadcyla (ado-trastuzumab emtansine)" + }, + { + "id": 8, + "document_id": 4, + "indication": "GILOTRIF is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test (1.1) Limitations of Use: Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations.", + "initial_approval_date": "2018-01-12", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201292s014lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to afatinib for the first-line treatment of patients with metastatic non-small lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.", + "raw_biomarkers": "non-resistant EGFR mutations", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Gilotrif (afatinib)" + }, + { + "id": 9, + "document_id": 5, + "indication": "ALECENSA is a kinase inhibitor indicated for the adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors >= 4 cm or node positive) as detected by an FDA-approved test.", + "initial_approval_date": "2024-04-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208434s015lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to alectinib for the adjuvant treatment of adult patients, following tumor resection, with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors >= 4 cm or node positive), as detected by an FDA-approved test.", + "raw_biomarkers": "ALK-positive", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "Alecensa (alectinib)" + }, + { + "id": 10, + "document_id": 5, + "indication": "ALECENSA is a kinase inhibitor indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.", + "initial_approval_date": "2017-11-06", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208434s003lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to alectinib for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.", + "raw_biomarkers": "ALK-positive", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Alecensa (alectinib)", + "date_regular_approval": "2017-11-06", + "date_accelerated_approval": "2015-12-11" + }, + { + "id": 11, + "document_id": 6, + "indication": "PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.", + "initial_approval_date": "2024-01-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212526s009lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to alpelisib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test, following progression on or after an endocrine-based regimen.", + "raw_biomarkers": "HR+, HER2-negative, PIK3CA-mutated", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Piqray (alpelisib) in combination with fulvestrant" + }, + { + "id": 12, + "document_id": 7, + "indication": "RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.", + "initial_approval_date": "2024-03-01", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s003lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to amivantamab-vmjw in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.", + "raw_biomarkers": "EGFR exon 20 insertion mutations", + "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer", + "raw_therapeutics": "Rybrevant (amivantamab-vmjw) in combination with carboplatin and pemetrexed" + }, + { + "id": 13, + "document_id": 7, + "indication": "RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.", + "initial_approval_date": "2024-03-01", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s003lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to amivantamab-vmjw for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.", + "raw_biomarkers": "EGFR exon 20 insertion mutations", + "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer", + "raw_therapeutics": "Rybrevant (amivantamab-vmjw)", + "date_regular_approval": "2024-03-01", + "date_accelerated_approval": "2021-05-21" + }, + { + "id": 14, + "document_id": 8, + "indication": "TRISENOX is an arsenical indicated in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.", + "initial_approval_date": "2018-01-12", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021248s015lbledt.pdf", + "description": "The U.S. Food and Drug Administration granted approval to arsenic trioxide in combination with tretinoin for the treatment of adult patients with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.", + "raw_biomarkers": "t(15;17) translocation or PML/RAR-alpha gene expression", + "raw_cancer_type": "low-risk acute promyelocytic leukemia (APL)", + "raw_therapeutics": "Trisenox (arsenic trioxide)" + }, + { + "id": 15, + "document_id": 8, + "indication": "TRISENOX is an arsenical indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.", + "initial_approval_date": "2000-09-25", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21248lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to arsenic trioxide for the induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.", + "raw_biomarkers": "t(15;17) translocation or PML/RAR-alpha gene expression", + "raw_cancer_type": "acute promyelocytic leukemia (APL)", + "raw_therapeutics": "Trisenox (arsenic trioxide)" + }, + { + "id": 16, + "document_id": 9, + "indication": "SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with previously treated philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).", + "initial_approval_date": "2022-10-12", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215358s001lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to asciminib for the treatment of adult patients with previously treated philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)", + "raw_therapeutics": "Scemblix (asciminib)" + }, + { + "id": 17, + "document_id": 9, + "indication": "SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with Ph+ CML in CP with the T315I mutation.", + "initial_approval_date": "2021-10-29", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000Orig1lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to asciminib for the treatment of adult patients with philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) with the T315I mutation.", + "raw_biomarkers": "philadelphia chromosome-positive with the T315I mutation", + "raw_cancer_type": "philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)", + "raw_therapeutics": "Scemblix (asciminib)" + }, + { + "id": 18, + "document_id": 10, + "indication": "TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on >= 1% of tumor cells, as determined by an FDA-approved test.", + "initial_approval_date": "2021-10-15", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034Orig1s042lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to atezolizumab for the adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on >= 1% of tumor cells, as determined by an FDA-approved test.", + "raw_biomarkers": "PD-L1 expression on >= 1% of tumor cells", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "Tecentriq (atezolizumab)" + }, + { + "id": 19, + "document_id": 10, + "indication": "TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained >= 50% of tumor cells [TC >= 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering >= 10% of the tumor area [IC >= 10%] ), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.", + "initial_approval_date": "2020-05-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s027lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to atezolizumab for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained >= 50% of tumor cells [TC >= 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering >= 10% of the tumor area [IC >= 10%] ), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.", + "raw_biomarkers": "PD-L1 stained >= 50% of tumor cells [TC >= 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering >= 10% of the tumor area [IC >= 10%])", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Tecentriq (atezolizumab)" + }, + { + "id": 20, + "document_id": 10, + "indication": "TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.", + "initial_approval_date": "2018-12-06", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s009lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to atezolizumab in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.", + "raw_biomarkers": "no EGFR or ALK genomic tumor aberrations", + "raw_cancer_type": "metastatic non-squamous non-small cell lung cancer", + "raw_therapeutics": "Tecentriq (atezolizumab) in combination with bevacizumab, paclitaxel, and carboplatin" + }, + { + "id": 21, + "document_id": 10, + "indication": "TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.", + "initial_approval_date": "2019-12-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s021lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to atezolizumab in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.", + "raw_biomarkers": "no EGFR or ALK genomic tumor aberrations", + "raw_cancer_type": "metastatic non-squamous non-small cell lung cancer", + "raw_therapeutics": "Tecentriq (atezolizumab) in combination with paclitaxel protein-bound and carboplatin" + }, + { + "id": 22, + "document_id": 10, + "indication": "TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.", + "initial_approval_date": "2017-04-17", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761034s001lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to atezolizumab for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving atezolizumab.", + "raw_biomarkers": "EGFR or ALK genomic tumor aberrations", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Tecentriq (atezolizumab)" + }, + { + "id": 23, + "document_id": 10, + "indication": "TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.", + "initial_approval_date": "2020-07-30", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s028lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to atezolizumab in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.", + "raw_biomarkers": "BRAF V600", + "raw_cancer_type": "unresectable or metastatic melanoma", + "raw_therapeutics": "Tecentriq (atezolizumab) in combination with cobimetinib and vemurafenib" + }, + { + "id": 24, + "document_id": 11, + "indication": "AYVAKIT is a kinase inhibitor indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.", + "initial_approval_date": "2021-06-16", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212608s006lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to avapritinib for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.", + "raw_biomarkers": "PDGFRA exon 18 mutation, including PDGFRA D842V", + "raw_cancer_type": "unresectable or metastatic GIST", + "raw_therapeutics": "Ayvakit (avapritinib)" + }, + { + "id": 25, + "document_id": 12, + "indication": "MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.", + "initial_approval_date": "2018-06-27", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210498lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to binimetinib in combination with encorafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.", + "raw_biomarkers": "BRAF V600E or V600K", + "raw_cancer_type": "unresectable or metastatic melanoma", + "raw_therapeutics": "Mektovi (binimetinib) in combination with encorafenib" + }, + { + "id": 26, + "document_id": 12, + "indication": "MEKTOVI is a kinase inhibitor indicated in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.", + "initial_approval_date": "2023-10-11", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210498s009lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to binimetinib in combination with encorafenib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Mektovi (binimetinib) in combination with encorafenib" + }, + { + "id": 27, + "document_id": 13, + "indication": "BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.", + "initial_approval_date": "2024-06-14", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557Orig1s028Correctedlbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to blinatumomab for the treatment of adult and pediatric patients one month and older with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.", + "raw_biomarkers": "CD19-positive", + "raw_cancer_type": "b-cell precursor acute lymphoblastic leukemia (ALL)", + "raw_therapeutics": "Blincyto (blinatumomab)" + }, + { + "id": 28, + "document_id": 13, + "indication": "BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).", + "initial_approval_date": "2024-06-14", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557Orig1s028Correctedlbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to blinatumomab for the treatment of adult and pediatric patients one month and older with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).", + "raw_biomarkers": "CD19-positive", + "raw_cancer_type": "b-cell precursor acute lymphoblastic leukemia (ALL)", + "raw_therapeutics": "Blincyto (blinatumomab)" + }, + { + "id": 29, + "document_id": 13, + "indication": "BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy.", + "initial_approval_date": "2024-06-14", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557Orig1s028Correctedlbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to blinatumomab for the treatment of adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy.", + "raw_biomarkers": "CD19-positive philadelphia chromosome-negative", + "raw_cancer_type": "b-cell precusor acute lymphoblastic leukemia (ALL)", + "raw_therapeutics": "Blincyto (blinatumomab)" + }, + { + "id": 30, + "document_id": 14, + "indication": "BOSULIF is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy.", + "initial_approval_date": "2023-09-23", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203341s025lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to bosutinib for the treatment of adult and pediatric patients 1 year of age and older with chronic phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy.", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "philadelphia chromosome-positive chronic myelogenous leukemia (CML)", + "raw_therapeutics": "Bosulif (bosutinib)" + }, + { + "id": 31, + "document_id": 14, + "indication": "BOSULIF is a kinase inhibitor indicated for the treatment of adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.", + "initial_approval_date": "2023-09-23", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203341s025lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to bosutinib for the treatment of adult patients with accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "philadelphia chromosome-positive chronic myelogenous leukemia (CML)", + "raw_therapeutics": "Bosulif (bosutinib)" + }, + { + "id": 32, + "document_id": 15, + "indication": "ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.", + "initial_approval_date": "2023-06-14", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125388s107lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to brentuximab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.", + "raw_biomarkers": "CD30-expressing", + "raw_cancer_type": "systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified", + "raw_therapeutics": "Adcetris (brentuximab vedotin) in combination with cyclophosphamide, doxorubicin, and prednisone" + }, + { + "id": 33, + "document_id": 15, + "indication": "ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.", + "initial_approval_date": "2023-06-14", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125388s107lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to brentuximab vedotin for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.", + "raw_biomarkers": "CD30-expressing", + "raw_cancer_type": "cutaneous analastplci large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF)", + "raw_therapeutics": "Adcetris (brentuximab vedotin)" + }, + { + "id": 34, + "document_id": 16, + "indication": "ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.", + "initial_approval_date": "2020-05-22", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208772s008lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to brigatinib for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.", + "raw_biomarkers": "ALK-positive", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Alunbrig (brigatinib)" + }, + { + "id": 35, + "document_id": 17, + "indication": "XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen.", + "initial_approval_date": "2022-12-14", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to capecitabine for the treatment of adult patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen.", + "raw_biomarkers": "HER2-overexpressing", + "raw_cancer_type": "metastatic gastric or gastroesophageal junction adenocarcinoma", + "raw_therapeutics": "Xeloda (capecitabine)" + }, + { + "id": 36, + "document_id": 18, + "indication": "TRUQAP is a kinase inhibitor indicated, in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.", + "initial_approval_date": "2023-11-16", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218197s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to capivasertib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.", + "raw_biomarkers": "HR+, HER2-negative with one or more PIK3CA/AKT1/PTEN-alterations", + "raw_cancer_type": "locally advanced or metastatic breast cancer", + "raw_therapeutics": "Truqaf (capivasertib) in combination with fulvestrant" + }, + { + "id": 37, + "document_id": 19, + "indication": "TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.", + "initial_approval_date": "2022-08-10", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s004lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to capmatinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.", + "raw_biomarkers": "MET exon 14 skipping", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Tabrecta (capmatinib)" + }, + { + "id": 38, + "document_id": 20, + "indication": "LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated in combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic.", + "initial_approval_date": "2022-11-08", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761097s014lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to cemiplimab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic.", + "raw_biomarkers": "no EGFR, ALK or ROS1 aberrations", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "Libtayo (cemiplimab) in combination with platinum-based chemotherapy" + }, + { + "id": 39, + "document_id": 20, + "indication": "LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated as single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) >= 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic.", + "initial_approval_date": "2021-02-22", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761097s007lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to cemiplimab for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) >= 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic.", + "raw_biomarkers": "high PD-L1 expression [Tumor Proportion Score (TPS) >= 50%] with no EGFR, ALK or ROS1 aberrations", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "Libtayo (cemiplimab)" + }, + { + "id": 40, + "document_id": 21, + "indication": "ZYKADIA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.", + "initial_approval_date": "2019-03-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211225s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ceritinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.", + "raw_biomarkers": "ALK-positive", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Zykadia (ceritinib)" + }, + { + "id": 41, + "document_id": 22, + "indication": "ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment.", + "initial_approval_date": "2012-07-06", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s225lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to cetuximab in combination with FOLFIRI for the first-line treatment of patients with K-Ras wild-type, EGFR-expressing metastatic colorectal cancer as determined by an FDA-approved test.", + "raw_biomarkers": "K-Ras wild type, EGFR-expressing", + "raw_cancer_type": "metastatic colorectal cancer", + "raw_therapeutics": "Erbitux (cetuximab) in combination with FOLFIRI" + }, + { + "id": 42, + "document_id": 22, + "indication": "ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy.", + "initial_approval_date": "2012-07-06", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s225lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to cetuximab in combination with irinotecan for the treatment of patients with K-Ras wild-type, EGFR-expressing metastatic colorectal", + "raw_biomarkers": "K-Ras wild-type, EGFR-expressing", + "raw_cancer_type": "metastatic colorectal cancer", + "raw_therapeutics": "Erbitux (cetuximab) in combination with irinotecan" + }, + { + "id": 43, + "document_id": 22, + "indication": "ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.", + "initial_approval_date": "2012-07-06", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s225lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to cetuximab for the treatment of patients with K-Ras wild-type, EGFR-expressing metastatic colorectal cancer, as determined by an FDA-approved test, who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.", + "raw_biomarkers": "K-Ras wild type, EGFR-expressing", + "raw_cancer_type": "metastatic colorectal cancer", + "raw_therapeutics": "Erbitux (cetuximab)" + }, + { + "id": 44, + "document_id": 22, + "indication": "ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.", + "initial_approval_date": "2021-09-24", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to cetuximab in combination with encorafenib for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "metastatic colorectal cancer", + "raw_therapeutics": "Erbitux (cetuximab) in combination with encorafenib" + }, + { + "id": 45, + "document_id": 23, + "indication": "COTELLIC is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.", + "initial_approval_date": "2015-11-10", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206192s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to cobimetinib in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.", + "raw_biomarkers": "BRAF V600E or V600K", + "raw_cancer_type": "unresectable or metastatic melanoma", + "raw_therapeutics": "Cotellic (cobimetinib) in combination with vemurafenib" + }, + { + "id": 46, + "document_id": 24, + "indication": "XALKORI is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.", + "initial_approval_date": "2017-07-21", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s021lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to crizotinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive, as detected by an FDA-approved test.", + "raw_biomarkers": "ALK or ROS1-positive", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Xalkori (crizotinib)" + }, + { + "id": 47, + "document_id": 24, + "indication": "XALKORI is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL", + "initial_approval_date": "2021-01-14", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202570s030lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to crizotinib for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.", + "raw_biomarkers": "ALK-positive", + "raw_cancer_type": "anaplastic large cell lymphoma (ALCL)", + "raw_therapeutics": "Xalkori (crizotinib)" + }, + { + "id": 48, + "document_id": 24, + "indication": "XALKORI is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.", + "initial_approval_date": "2022-07-14", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202570s033lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to crizotinib for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.", + "raw_biomarkers": "ALK-positive", + "raw_cancer_type": "unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT)", + "raw_therapeutics": "Xalkori (crizotinib)" + }, + { + "id": 49, + "document_id": 25, + "indication": "TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test", + "initial_approval_date": "2013-05-29", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "unresectable or metastatic melanoma", + "raw_therapeutics": "Tafinlar (dabrafenib)" + }, + { + "id": 50, + "document_id": 25, + "indication": "TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.", + "initial_approval_date": "2015-11-20", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202806s004lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dabrafenib in combination with trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.", + "raw_biomarkers": "BRAF V600E or BRAF V600K", + "raw_cancer_type": "unresectable or metastatic melanoma", + "raw_therapeutics": "Tafinlar (dabrafenib) in combination with trametinib" + }, + { + "id": 51, + "document_id": 25, + "indication": "TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.", + "initial_approval_date": "2018-04-30", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s008lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dabrafenib in combination with trametinib for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.", + "raw_biomarkers": "BRAF V600E or BRAF V600K", + "raw_cancer_type": "melanoma", + "raw_therapeutics": "Tafinlar (dabrafenib) in combination with trametinib" + }, + { + "id": 52, + "document_id": 25, + "indication": "TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.", + "initial_approval_date": "2017-06-22", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202806s006lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dabrafenib in combination with trametinib for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Tafinlar (dabrafenib) in combination with trametinib" + }, + { + "id": 53, + "document_id": 25, + "indication": "TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.", + "initial_approval_date": "2018-05-04", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s010lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dabrafenib in combination with trametinib for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "locally advanced or metastatic anaplastic thyroid cancer (ATC)", + "raw_therapeutics": "Tafinlar (dabrafenib) in combination with trametinib" + }, + { + "id": 54, + "document_id": 25, + "indication": "TAFINLAR is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "initial_approval_date": "2022-06-22", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806s022lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to dabrafenib in combination with trametinib for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "unresectable or metastatic solid tumors", + "raw_therapeutics": "Tafinlar (dabrafenib) in combination with trametinib" + }, + { + "id": 55, + "document_id": 25, + "indication": "TAFINLAR is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.", + "initial_approval_date": "2023-03-16", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202806s025lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dabrafenib in combination with trametinib for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "low-grade glioma (LGG)", + "raw_therapeutics": "Tafinlar (dabrafenib) in combination with trametinib" + }, + { + "id": 56, + "document_id": 26, + "indication": "VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test", + "initial_approval_date": "2018-09-27", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211288s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dacomitinib for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by an FDA-approved test.", + "raw_biomarkers": "EGFR exon 19 deletion or exon 21 L858R substitution mutations", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Vizimpro (dacomitinib)" + }, + { + "id": 57, + "document_id": 27, + "indication": "SPRYCEL is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.", + "initial_approval_date": "2015-08-12", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dasatinib for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.", + "raw_biomarkers": "philadelphia chromosome-positive (Ph+)", + "raw_cancer_type": "philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)", + "raw_therapeutics": "Sprycel (dasatinib)" + }, + { + "id": 58, + "document_id": 27, + "indication": "SPRYCEL is a kinase inhibitor indicated for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.", + "initial_approval_date": "2010-07-28", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dasatinib for the treatment of adult patients with chronic, accelerated, or myeloid or lymphoid blast phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib.", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML", + "raw_therapeutics": "Sprycel (dasatinib)" + }, + { + "id": 59, + "document_id": 27, + "indication": "SPRYCEL is a kinase inhibitor indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.", + "initial_approval_date": "2006-06-28", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021986lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dasatinib for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)", + "raw_therapeutics": "Sprycel (dasatinib)" + }, + { + "id": 60, + "document_id": 27, + "indication": "SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase.", + "initial_approval_date": "2018-12-21", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s021lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dasatinib for the treatment of pediatric patients 1 year of age and older with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.", + "raw_biomarkers": "philadelphia chromosome-positive (Ph+)", + "raw_cancer_type": "philadelphia chromosome-positive CML", + "raw_therapeutics": "Sprycel (dasatinib)" + }, + { + "id": 61, + "document_id": 27, + "indication": "SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ", + "initial_approval_date": "2018-12-21", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s021lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dasatinib in combination with chemotherapy for the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).", + "raw_biomarkers": "philadelphia chromosome-positive (Ph+)", + "raw_cancer_type": "philadelphia chromosome-positive ALL", + "raw_therapeutics": "Sprycel (dasatinib) in combination with chemotherapy" + }, + { + "id": 62, + "document_id": 28, + "indication": "JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microstallite instability-high (MSI-H).", + "initial_approval_date": "2023-07-31", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s006lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dostarlimab in combination with carboplatin and paclitaxel, followed by dostarlimab as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microstallite instability-high (MSI-H).", + "raw_biomarkers": "mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H)", + "raw_cancer_type": "primary advanced or recurrent endometrial cancer", + "raw_therapeutics": "Jemperli (dostarlimab) in combination with carboplatin and paclitaxel" + }, + { + "id": 63, + "document_id": 28, + "indication": "JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.", + "initial_approval_date": "2023-02-09", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s003s004lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to dostarlimab for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.", + "raw_biomarkers": "dMMR", + "raw_cancer_type": "recurrent or advanced endometrial cancer", + "raw_therapeutics": "Jemperli (dostarlimab)" + }, + { + "id": 64, + "document_id": 28, + "indication": "JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "initial_approval_date": "2022-04-28", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761174s002lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to dostarlimab for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-Approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.", + "raw_biomarkers": "dMMR", + "raw_cancer_type": "recurrent or advanced solid tumors", + "raw_therapeutics": "Jemperli (dostarlimab)" + }, + { + "id": 65, + "document_id": 29, + "indication": "IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic aberrations.", + "initial_approval_date": "2022-11-10", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761069s033lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to durvalumab in combination with tremelimumab-actl and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic aberrations. This indication is based on POSEIDON (NCT03164616), a randomized, open-label, and multicenter study where patients received one of the following chemotherapy regimes: pemetrexed in combination with carboplatin or cisplatin for patients with non-squamous NSCLC, gemcitabine with cisplatin or carboplatin for patients with squamous NSCLC, and nab-paclitaxel with carboplatin for either non-squamous or squamous NSCLC.", + "raw_biomarkers": "no sensitizing EGFR mutations or ALK genomic aberrations", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Imfinzi (durvalumab) in combination with tremelimumab-actl and platinum-based chemotherapy" + }, + { + "id": 66, + "document_id": 29, + "indication": "IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).", + "initial_approval_date": "2024-06-14", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s045lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to durvalumab in combination with carboplatin and paclitaxel, followed by durvalumab as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).", + "raw_biomarkers": "mismatch repair deficient (dMMR)", + "raw_cancer_type": "primary advanced or recurrent endometrial cancer", + "raw_therapeutics": "Imfinzi (durvalumab) in combination with carboplatin and paclitaxel" + }, + { + "id": 67, + "document_id": 30, + "indication": "ORSERDU is an estrogen receptor antagonist indicated for treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.", + "initial_approval_date": "2023-01-27", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s000correctedlbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to elacestrant for the treatment of patients who are postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.", + "raw_biomarkers": "ER-positive, HER2-negative, ESR1-mutated", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Orserdu (elacestrant)" + }, + { + "id": 68, + "document_id": 31, + "indication": "IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.", + "initial_approval_date": "2017-08-01", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to enasidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.", + "raw_biomarkers": "IDH2 mutation", + "raw_cancer_type": "relapsed or refractory acute myeloid leukemia (AML)", + "raw_therapeutics": "Idhifa (enasidenib)" + }, + { + "id": 69, + "document_id": 32, + "indication": "BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.", + "initial_approval_date": "2018-06-27", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to encorafenib in combination with binimetinib for the treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Encorafenib's package insert further states that it is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF non-small cell lung cancer.", + "raw_biomarkers": "BRAF V600E or BRAF V600K", + "raw_cancer_type": "unresectable or metastatic melanoma", + "raw_therapeutics": "Braftovi (encorafenib) in combination with binimetinib" + }, + { + "id": 70, + "document_id": 32, + "indication": "BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.", + "initial_approval_date": "2020-04-08", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210496s006lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to encorafenib in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. Encorafenib's package insert further states that it is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF non-small cell lung cancer.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "metastatic colorectal cancer", + "raw_therapeutics": "Braftovi (encorafenib) in combination with cetuximab" + }, + { + "id": 71, + "document_id": 32, + "indication": "BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.", + "initial_approval_date": "2023-10-11", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210496s014lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to encorafenib in combination with binimetinib for the treatment of adult patients with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test. Encorafenib's package insert further states that it is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF non-small cell lung cancer.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Braftovi (encorafenib) in combination with binimetinib" + }, + { + "id": 72, + "document_id": 33, + "indication": "ROZLYTREK is a kinase inhibitor indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.", + "initial_approval_date": "2019-08-15", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212725s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to entrectinib for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.", + "raw_biomarkers": "ROS1-positive", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Rozlytrek (entrectinib)" + }, + { + "id": 73, + "document_id": 33, + "indication": "ROZLYTREK is a kinase inhibitor indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, (ii) are metastatic or where surgical resection is likely to result in severe morbidity, and (iii) have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.", + "initial_approval_date": "2023-10-20", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212725Orig1s009Correctedlbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to entrectinib for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, (ii) are metastatic or where surgical resection is likely to result in severe morbidity, and (iii) have progressed following treatment or have no satisfactory alternative therapy. Entrectinib's package insert further states that this indication is approved under accelerated approval based on tumor response rate and durability of response. Furthermore, continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.", + "raw_biomarkers": "NTRK gene fusion", + "raw_cancer_type": "solid tumors", + "raw_therapeutics": "Rozlytrek (entrectinib)" + }, + { + "id": 74, + "document_id": 34, + "indication": "BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.", + "initial_approval_date": "2024-01-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212018s007s008s009lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib's product label states for patients to be selected for therapy based on an FDA-approved companion diagnostic for erdafitinib. Furthermore, erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.", + "raw_biomarkers": "susceptible FGFR3 genetic alterations", + "raw_cancer_type": "locally advanced or metastatic urothelial carcinoma (mUC)", + "raw_therapeutics": "Balversa (erdafitinib)" + }, + { + "id": 75, + "document_id": 35, + "indication": "TARCEVA is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Safety and efficacy of TARCEVA have not been established in patients with NSCLC whose tumors have other EGFR mutations. TARCEVA is not recommended for use in combination with platinum-based chemotherapy.", + "initial_approval_date": "2016-10-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to erlotinib for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test, receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Erlotnib's product label further states that safety and efficacy of erlotnib have not been established in patients with NSCLC whose tumors have other EGFR mutations. Furthermore, the product label states that it is not recommended for use in combination with platinum-based chemotherapy.", + "raw_biomarkers": "EGFR exon 19 deletions or exon 21 L858R", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Tarceva (erlotinib)" + }, + { + "id": 76, + "document_id": 36, + "indication": "AFINITOR is a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2 negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.", + "initial_approval_date": "2012-07-20", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s016lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to everolimus in combination with exemestane for the treatment of patients who are postmenopausal women with advanced hormone receptor-positive, HER2 negative breast cancer after failure of treatment with letrozole or anastrozole.", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "breast cancer", + "raw_therapeutics": "Afinitor (everolimus)" + }, + { + "id": 77, + "document_id": 37, + "indication": "FASLODEX is an estrogen receptor antagonist indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.", + "initial_approval_date": "2017-08-25", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344s034lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to fulvestrant for the treatment of patients who are postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer not previously treated with endocrine therapy.", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "breast cancer", + "raw_therapeutics": "Faslodex (fulvestrant)" + }, + { + "id": 78, + "document_id": 37, + "indication": "FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.", + "initial_approval_date": "2002-04-25", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21344lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to fulvestrant for the treatment of patients who are postmenopausal women with hormone receptor (HR)-positive advanced breast cancer with disease progression following endocrine therapy.", + "raw_biomarkers": "HR+", + "raw_cancer_type": "breast cancer", + "raw_therapeutics": "Faslodex (fulvestrant)" + }, + { + "id": 79, + "document_id": 37, + "indication": "FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy.", + "initial_approval_date": "2019-03-11", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021344s037lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to fulvestrant in combination with ribociclib for the treatment of patients who are postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Faslodex (fulvestrant) in combination with ribociclib" + }, + { + "id": 80, + "document_id": 37, + "indication": "FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.", + "initial_approval_date": "2017-08-25", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021344s035lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to fulvestrant in combination with either palbociclib or abemaciclib for the treatment of patients who are women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer with disease after endocrine therapy.", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Faslodex (fulvestrant) in combination with palbociclib or abemaciclib" + }, + { + "id": 81, + "document_id": 38, + "indication": "LYTGOBI is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "initial_approval_date": "2022-09-30", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214801Orig1s000lbledt.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to futibatinib for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. Futibatinib's package insert states that this indication is approved under accelerated approval based on overall response rate and duration of response. Furthermore, continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "raw_biomarkers": "FGFR2 gene fusions or other rearrangements", + "raw_cancer_type": "unresectable, locally or metastatic intrahepatic cholangiocarcinoma", + "raw_therapeutics": "Lytgobi (futibatinib)" + }, + { + "id": 82, + "document_id": 39, + "indication": "IRESSA is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Limitation of Use: Safety and efficacy of IRESSA have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.", + "initial_approval_date": "2015-07-13", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206995s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to gefitinib for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test. Gefitinib's package insert includes the following limitation of use: safety and efficacy of gefitinib have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.", + "raw_biomarkers": "EGFR exon 19 deletions or exon 21 (L858R) substitution mutations", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Iressa (gefitinib)" + }, + { + "id": 83, + "document_id": 40, + "indication": "MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older.", + "initial_approval_date": "2020-06-16", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761060s004lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to gemtuzumab ozogamicin for the treatment of adult and pediatric patients aged 1 month or older with newly-diagnosed CD33-positive acute myeloid leukemia (AML).", + "raw_biomarkers": "CD33-positive", + "raw_cancer_type": "acute myeloid leukemia", + "raw_therapeutics": "Mylotarg (gemtuzumab ozogamicin)" + }, + { + "id": 84, + "document_id": 40, + "indication": "MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older.", + "initial_approval_date": "2017-09-01", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761060lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to gemtuzumab ozogamicin for the treatment of adult and pediatric patients aged 2 years and older with relapsed or refractory CD33-positive acute myeloid leukemia (AML).", + "raw_biomarkers": "CD33-positive", + "raw_cancer_type": "acute myeloid leukemia", + "raw_therapeutics": "Mylotarg (gemtuzumab ozogamicin)" + }, + { + "id": 85, + "document_id": 41, + "indication": "XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.", + "initial_approval_date": "2018-11-28", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211349s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation, as detected by an FDA-approved test.", + "raw_biomarkers": "FLT3 mutation", + "raw_cancer_type": "relapsed or refractory acute myeloid leukemia", + "raw_therapeutics": "Xospata (gilteritinib)" + }, + { + "id": 86, + "document_id": 42, + "indication": "Gleevec is a kinase inhibitor indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.", + "initial_approval_date": "2006-09-27", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s016lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to imatinib for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "philadelphia chromosome-positive chronic myeloid leukemia", + "raw_therapeutics": "Gleevec (imatinib)" + }, + { + "id": 87, + "document_id": 42, + "indication": "Gleevec is a kinase inhibitor indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy.", + "initial_approval_date": "2003-04-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to imatinib for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy.", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "philadelphia chromosome-positive chronic myeloid leukemia", + "raw_therapeutics": "Gleevec (imatinib)" + }, + { + "id": 88, + "document_id": 42, + "indication": "Gleevec is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).", + "initial_approval_date": "2006-10-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to imatinib for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "philadelphia chromosome-positive acute lymphoblastic leukemia", + "raw_therapeutics": "Gleevec (imatinib)" + }, + { + "id": 89, + "document_id": 42, + "indication": "Gleevec is a kinase inhibitor indicated for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.", + "initial_approval_date": "2013-01-25", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s037lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to imatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "philadelphia chromosome-positive acute lymphoblastic leukemia", + "raw_therapeutics": "Gleevec (imatinib) in combination with chemotherapy" + }, + { + "id": 90, + "document_id": 42, + "indication": "Gleevec is a kinase inhibitor indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.", + "initial_approval_date": "2006-10-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to imatinib for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.", + "raw_biomarkers": "platelet-derived growth factor receptor (PDGFR) gene re-arrangements", + "raw_cancer_type": "myelodyplastic/myeloproliferative diseases (MDS/MPD)", + "raw_therapeutics": "Gleevec (imatinib)" + }, + { + "id": 91, + "document_id": 42, + "indication": "Gleevec is a kinase inhibitor indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.", + "initial_approval_date": "2006-10-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to imatinib for the treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.", + "raw_biomarkers": "without the D816V c-Kit mutation or with the c-Kit mutational status unknown", + "raw_cancer_type": "aggressive systemic mastocytosis (ASM)", + "raw_therapeutics": "Gleevec (imatinib)" + }, + { + "id": 92, + "document_id": 42, + "indication": "Gleevec is a kinase inhibitor indicated for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRa fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase negative or unknown.", + "initial_approval_date": "2006-10-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to imatinib for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRa fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase negative or unknown.", + "raw_biomarkers": "FIP1L1-PDGFRa fusion kinase and for patients ... who are FIP1L1-PDGFRa fusion kinase negative or unknown", + "raw_cancer_type": "hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL)", + "raw_therapeutics": "Gleevec (imatinib)" + }, + { + "id": 93, + "document_id": 42, + "indication": "Gleevec is a kinase inhibitor indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).", + "initial_approval_date": "2003-04-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to imatinib for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).", + "raw_biomarkers": "Kit (CD117) positive", + "raw_cancer_type": "unresectable and/or metastatic maligant gastrointestinal stromal tumors (GIST)", + "raw_therapeutics": "Gleevec (imatinib)" + }, + { + "id": 94, + "document_id": 42, + "indication": "Gleevec is a kinase inhibitor indicated for the adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST.", + "initial_approval_date": "2012-01-31", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021588s035lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to imatinib for the adjuvant treatment of adult patients following resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST).", + "raw_biomarkers": "Kit (CD117) positive", + "raw_cancer_type": "GIST", + "raw_therapeutics": "Gleevec (imatinib)" + }, + { + "id": 95, + "document_id": 43, + "indication": "TRUSELTIQ is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).", + "initial_approval_date": "2021-05-28", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214622s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to infigratinib for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement, as detected by an FDA-approved test. The product label notes that this indication is approved under accelerated approval based on overall response rate and duration of response. Furthermore, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).", + "raw_biomarkers": "FGFR2 fusion or other rearrangement", + "raw_cancer_type": "unresectable locally advanced or metastatic cholangiocarcinoma", + "raw_therapeutics": "Truseltiq (infigratinib)" + }, + { + "id": 96, + "document_id": 44, + "indication": "BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.", + "initial_approval_date": "2024-03-06", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761040s003lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to inotuzumab ozogamicin for the treatment of adult and pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).", + "raw_biomarkers": "CD22-positive", + "raw_cancer_type": "B-cell precursor acute lymphoblastic leukemia (ALL)", + "raw_therapeutics": "Besponsa (inotuzumab ozogamicin)" + }, + { + "id": 97, + "document_id": 45, + "indication": "YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in combination with nivolumab. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "initial_approval_date": "2018-07-10", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ipilimumab in combination with nivolumab for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The package insert notes that this indication is approved under accelerated approval based on overall response rate and duration of response. Furthermore, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "raw_biomarkers": "microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)", + "raw_cancer_type": "metastatic colorectal cancer", + "raw_therapeutics": "Yervoy (ipilimumab) in combination with nivolumab" + }, + { + "id": 98, + "document_id": 45, + "indication": "YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>=1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab.", + "initial_approval_date": "2020-05-15", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s109lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ipilimumab in combination with nivolumab for the first-line treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>=1%), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations", + "raw_biomarkers": "PD-L1 >= 1% and no EGFR or ALK genomic tumor aberrations", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Yervoy (ipilimumab) in combination with nivolumab" + }, + { + "id": 99, + "document_id": 45, + "indication": "YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy.", + "initial_approval_date": "2020-05-26", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s110lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ipilimumab in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy for the treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This indication is based on CHECKMATE-9LA (NCT03215706), a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.", + "raw_biomarkers": "no EGFR or ALK genomic tumor aberrations", + "raw_cancer_type": "metastatic or recurrent non-small cell lung cancer", + "raw_therapeutics": "Yervoy (ipilimumab) in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy" + }, + { + "id": 100, + "document_id": 46, + "indication": "TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy", + "initial_approval_date": "2022-05-25", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211192s009lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ivosidenib as a monotherapy or in combination with azacitidine for the treatment of adult patients newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.", + "raw_biomarkers": "susceptible IDH1 mutation", + "raw_cancer_type": "acute myeloid leukemia", + "raw_therapeutics": "Tibsovo (ivosidenib) in combination with azacitidine or as monotherapy" + }, + { + "id": 101, + "document_id": 46, + "indication": "TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with relapsed or refractory AML.", + "initial_approval_date": "2018-07-20", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ivosidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test.", + "raw_biomarkers": "susceptible IDH1 mutation", + "raw_cancer_type": "relapsed or refractory AML", + "raw_therapeutics": "Tibsovo (ivosidenib)" + }, + { + "id": 102, + "document_id": 46, + "indication": "TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes.", + "initial_approval_date": "2023-10-24", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ivosidenib for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes with a susceptible IDH1 mutation, as detected by an FDA-approved test.", + "raw_biomarkers": "susceptible IDH1 mutation", + "raw_cancer_type": "relapsed or refractory myelodysplastic syndromes", + "raw_therapeutics": "Tibsovo (ivosidenib)" + }, + { + "id": 103, + "document_id": 46, + "indication": "TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.", + "initial_approval_date": "2021-08-25", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211192_s008lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ivosidenib for the treatment adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated with a susceptible IDH1 mutation, as detected by an FDA-approved test. This indication is based on Study AG120-C-005 (NCT02989857), a randomized, multicenter, double-blind, placebo-controlled clinical trial consisting of 185 adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation. The product label notes that, across both arms of the trial, patients primarily had R132 variants: R132C (70% of patients), R132L (15%), R132G (12%), R132H (1.1%), and R132S (1.6%).", + "raw_biomarkers": "susceptible IDH1 mutation", + "raw_cancer_type": "locally advanced or metastatic cholangiocarcinoma", + "raw_therapeutics": "Tibsovo (ivosidenib)" + }, + { + "id": 104, + "document_id": 47, + "indication": "TYKERB is a kinase inhibitor indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use: Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.", + "initial_approval_date": "2007-03-13", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, a trastuzumab. ", + "raw_biomarkers": "HER2 overexpression", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Tykerb (lapatinib) in combination with capecitabine" + }, + { + "id": 105, + "document_id": 47, + "indication": "TYKERB is a kinase inhibitor indicated in combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.", + "initial_approval_date": "2010-01-29", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to lapatinib in combination with letrozole for the treatment of patients who are postmenopausal women with hormone receptor-positive metastatic breast cancers that overexpresses the HER2 receptor for whom hormonal therapy is indicated. Lapatinib's product label notes that lapatinib in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.", + "raw_biomarkers": "HR+, HER2 overexpression", + "raw_cancer_type": "metastatic breast cancer", + "raw_therapeutics": "Tykerb (lapatinib) in combination with letrozole" + }, + { + "id": 106, + "document_id": 48, + "indication": "VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "initial_approval_date": "2018-11-26", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210861s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to larotrectinib for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Larotrectinib's product label specifies to select patients for therapy based on an FDA-approved test. Furthermore, it notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "raw_biomarkers": "NTRK gene fusion", + "raw_cancer_type": "solid tumors", + "raw_therapeutics": "Vitrakvi (larotrectinib)" + }, + { + "id": 107, + "document_id": 49, + "indication": "REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.", + "initial_approval_date": "2005-12-27", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021880lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to lenalidomide for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.", + "raw_biomarkers": "5q deletion", + "raw_cancer_type": "transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS)", + "raw_therapeutics": "Revlimid (lenalidomide)" + }, + { + "id": 108, + "document_id": 50, + "indication": "LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.", + "initial_approval_date": "2021-03-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s004lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to lorlatinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.", + "raw_biomarkers": "ALK-positive", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Lorbrena (lorlatinib)" + }, + { + "id": 109, + "document_id": 51, + "indication": "MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2- positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.", + "initial_approval_date": "2020-12-16", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761150s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to margetuximab-cmkb in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. This indication is based on SOPHIA (NCT02492711), a randomized, multicenter, open-label trial of 536 patients with IHC 3+ or ISH-amplified HER2+ metastatic breast cancer who had received prior treatment with other anti-HER2 therapies. Randomization within the trial was stratified by chemotherapy choice (capecitabine, eribulin, gemcitabine, or vinorelbine).", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "metastatic breast cancer", + "raw_therapeutics": "Margenza (margetuximab-cmkb) in combination with chemotherapy" + }, + { + "id": 110, + "document_id": 52, + "indication": "RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation- positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.", + "initial_approval_date": "2017-04-28", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to midostaurin in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive, as detected by an FDA-approved test. Midostaurin's product label notes that midostaurin is not indicated as a single-agent induction therapy for the treatment of patients with AML.", + "raw_biomarkers": "FLT3 mutation-positive", + "raw_cancer_type": "acute myeloid leukemia", + "raw_therapeutics": "Rydapt (midostaurin) in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation" + }, + { + "id": 111, + "document_id": 53, + "indication": "EXKIVITY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).", + "initial_approval_date": "2021-09-15", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215310s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The product label notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).", + "raw_biomarkers": "EGFR exon 20 insertion mutations", + "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer", + "raw_therapeutics": "Exkivity (mobocertinib)" + }, + { + "id": 112, + "document_id": 54, + "indication": "NERLYNX is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab based therapy.", + "initial_approval_date": "2019-10-01", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208051s004lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to neratinib for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab based therapy.", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "early-stage breast cancer", + "raw_therapeutics": "Nerlynx (neratinib)" + }, + { + "id": 113, + "document_id": 54, + "indication": "NERLYNX is a kinase inhibitor indicated in combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.", + "initial_approval_date": "2020-02-25", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208051s005s006lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Nerlynx (neratinib) in combination with capecitabine" + }, + { + "id": 114, + "document_id": 55, + "indication": "Tasigna is a kinase inhibitor indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.", + "initial_approval_date": "2018-03-22", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022068s027lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to nilotinib for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "philadelphia chromosome-positive chronic myeloid (Ph+ CML)", + "raw_therapeutics": "Tasigna (nilotinib)" + }, + { + "id": 115, + "document_id": 55, + "indication": "Tasigna is a kinase inhibitor indicated for the treatment of adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.", + "initial_approval_date": "2007-10-29", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022068lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to nilotinib for the treatment of adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "chronic phase or accelerated phase Ph+ CML", + "raw_therapeutics": "Tasigna (nilotinib)" + }, + { + "id": 116, + "document_id": 55, + "indication": "Tasigna is a kinase inhibitor indicated for the treatment of pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.", + "initial_approval_date": "2018-03-22", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022068s027lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to nilotinib for the treatment of pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "Ph+ CML-CP and CML-AP", + "raw_therapeutics": "Tasigna (nilotinib)" + }, + { + "id": 117, + "document_id": 56, + "indication": "ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.", + "initial_approval_date": "2023-04-26", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214876s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to niraparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Niraparib's product label states to select patients for therapy based on an FDA-approved companion diagnostic for niraparib.", + "raw_biomarkers": "deleterious or suspected deleterious germline BRCA-mutated", + "raw_cancer_type": "recurrent epithelial ovarian, fallopian tubem or primary peritoneal cancer", + "raw_therapeutics": "Zejula (niraparib)" + }, + { + "id": 118, + "document_id": 57, + "indication": "OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of adult patients with resectable (tumors >=4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery.", + "initial_approval_date": "2024-10-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s127lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to nivolumab in combination with platinum-doublet chemotherapy for the neoadjuvant treatment, followed by single-agent nivolumab as adjuvant treatment after surgery, of adult patients with resectable (tumors >= 4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements. This indication is based on CHECKMATE-816 (NCT02998528), a randomized, open label trial where patients received either: carboplatin with paclitaxel for either histology, cisplatin with pemetrexed for non-squamous histology, or cisplatin with gemcitabine for squamous histology.", + "raw_biomarkers": "no known EGFR mutations or ALK rearrangement", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "Opdivo (nivolumab) in combination with platinum-doublet chemotherapy" + }, + { + "id": 119, + "document_id": 58, + "indication": "Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "initial_approval_date": "2018-12-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s006lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "raw_biomarkers": "deleterious or suspected deleterious germline or somatic BRCA-mutated", + "raw_cancer_type": "advanced epithelial ovarian, fallopian tube or primary peritoneal cancer", + "raw_therapeutics": "Lynparza (olaparib)" + }, + { + "id": 120, + "document_id": 58, + "indication": "Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "initial_approval_date": "2020-05-08", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s013lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to olaparib in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "raw_biomarkers": "HRD-positive defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability", + "raw_cancer_type": "advanced epithelial ovarian, fallopian tube or primary peritoneal cancer", + "raw_therapeutics": "Lynparza (olaparib) in combination with bevacizumab" + }, + { + "id": 121, + "document_id": 58, + "indication": "Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "initial_approval_date": "2023-09-12", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s029lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "raw_biomarkers": "deleterious or suspected deleterious germline or somatic BRCA-mutated", + "raw_cancer_type": "relapsed epithelial ovarian, fallopian tube or primary peritoneal cancer", + "raw_therapeutics": "Lynparza (olaparib)" + }, + { + "id": 122, + "document_id": 58, + "indication": "Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "initial_approval_date": "2022-03-11", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s023lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to olaparib for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "raw_biomarkers": "deleterious or suspected deleterious gBRCAm, HER2-negative", + "raw_cancer_type": "high risk early breast cancer", + "raw_therapeutics": "Lynparza (olaparib)" + }, + { + "id": 123, + "document_id": 58, + "indication": "Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "initial_approval_date": "2018-01-12", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s001lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to olaparib for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Olaparib's product label states that patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. The product label also states to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "raw_biomarkers": "deleterious or suspected deleterious gBRCAm, HER2-negative", + "raw_cancer_type": "metastatic breast cancer", + "raw_therapeutics": "Lynparza (olaparib)" + }, + { + "id": 124, + "document_id": 58, + "indication": "Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "initial_approval_date": "2019-12-27", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208558Orig1s010lblrpl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "raw_biomarkers": "deleterious or suspected deleterious gBRCAm", + "raw_cancer_type": "metastatic pancreatic adenocarcinoma", + "raw_therapeutics": "Lynparza (olaparib)" + }, + { + "id": 125, + "document_id": 58, + "indication": "Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "initial_approval_date": "2020-05-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s014lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to olaparib for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "raw_biomarkers": "deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated", + "raw_cancer_type": "metastatic castration-resistant prostate cancer", + "raw_therapeutics": "Lynparza (olaparib)" + }, + { + "id": 126, + "document_id": 58, + "indication": "Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "initial_approval_date": "2023-05-31", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s025lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to olaparib in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Olaparib's product label states to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.", + "raw_biomarkers": "deleterious or suspected deleterious BRCA-mutated", + "raw_cancer_type": "metastatic castration-resistant prostate cancer", + "raw_therapeutics": "Lynparza (olaparib) in combination with abiraterone and prednisolone or prednisone" + }, + { + "id": 127, + "document_id": 59, + "indication": "REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.", + "initial_approval_date": "2022-12-01", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215814s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to olutasidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test.", + "raw_biomarkers": "susceptible IDH1 mutation", + "raw_cancer_type": "relapsed or refractory acute myeloid leukemia (AML)", + "raw_therapeutics": "Rezlidhia (olutasidenib)" + }, + { + "id": 128, + "document_id": 60, + "indication": "TAGRISSO is a kinase inhibitor indicated for adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.", + "initial_approval_date": "2020-12-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s021lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to osimertinib for the adjuvant treatment after tumor resection of adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.", + "raw_biomarkers": "EGFR exon 19 deletions or exon 21 L858R mutations", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "Tagrisso (osimertinib)" + }, + { + "id": 129, + "document_id": 60, + "indication": "TAGRISSO is a kinase inhibitor indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.", + "initial_approval_date": "2018-04-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s008lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to osimertinib for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.", + "raw_biomarkers": "EGFR exon 19 deletions or exon 21 L858R mutations", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Tagrisso (osimertinib)" + }, + { + "id": 130, + "document_id": 60, + "indication": "TAGRISSO is a kinase inhibitor indicated in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.", + "initial_approval_date": "2024-02-16", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s030lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. This indication is based on FLAURA2 (NCT04035486), a randomized, multicenter, and open-label trial where patients were randomized to receive either osimertinib or osimertinib in combination with pemetrexed and investigator's choice of either cisplatin or carboplatin.", + "raw_biomarkers": "EGFR exon 19 deletions or exon 21 L858R mutations", + "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer", + "raw_therapeutics": "Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy" + }, + { + "id": 131, + "document_id": 60, + "indication": "TAGRISSO is a kinase inhibitor indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.", + "initial_approval_date": "2017-03-30", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s006lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to osimertinib for the treatment of adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.", + "raw_biomarkers": "EGFR T790M", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Tagrisso (osimertinib)" + }, + { + "id": 132, + "document_id": 61, + "indication": "IBRANCE is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy.", + "initial_approval_date": "2019-09-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207103s015lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to palbociclib in combination with an aromatase inhibitor as an initial endocrine-based therapy for treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This indication is based on PALOMA-2 (NCT01740427), an international, randomized, double-blind, parallel-group, multicenter study of palbociclib plus letrozole versus placebo plus letrozole.", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Ibrance (palbociclib) in combination with an aromatase inhibitor" + }, + { + "id": 133, + "document_id": 61, + "indication": "IBRANCE is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant in patients with disease progression following endocrine therapy.", + "initial_approval_date": "2016-02-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207103s002lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to palbociclib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.", + "raw_biomarkers": "HR+, HER2-negative", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Ibrance (palbociclib) in combination with fulvestrant" + }, + { + "id": 134, + "document_id": 62, + "indication": "Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) in combination with FOLFOX for first-line treatment. Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.", + "initial_approval_date": "2021-08-25", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125147s210lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to panitumumab in combination with FOLFOX for the first-line treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRAS, as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC). The product label specifies a limitation of use that panitumumab is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.", + "raw_biomarkers": "wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use)", + "raw_cancer_type": "metastatic colorectal cancer", + "raw_therapeutics": "Vectibix (panitumumab) in combination with folfox" + }, + { + "id": 135, + "document_id": 62, + "indication": "Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. Limitation of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.", + "initial_approval_date": "2021-08-25", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125147s210lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to panitumumab for the treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC)following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. The product label specifies a limitation of use that panitumumab is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.", + "raw_biomarkers": "wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use)", + "raw_cancer_type": "metastatic colorectal cancer", + "raw_therapeutics": "Vectibix (panitumumab)" + }, + { + "id": 136, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.", + "initial_approval_date": "2018-08-20", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s035lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. This indication is based on KEYNOTE-189 (NCT02578680), a randomized, multicenter, double-blind, active-controlled trial conducted in 616 patients where the choice of platinum-containing chemotherapy was either carboplatin or cisplatin.", + "raw_biomarkers": "no EGFR or ALK genomic tumor aberrations", + "raw_cancer_type": "metastatic non-squamous non-small cell lung cancer", + "raw_therapeutics": "Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy" + }, + { + "id": 137, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) >=1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.", + "initial_approval_date": "2019-04-11", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s047lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab for the first-line treatment of patients with non-small cell lung cancer expressing PD-L1 [Tumor Proportion Score (TPS) >=1%], as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.", + "raw_biomarkers": "no EGFR or ALK genomic tumor aberrations, and PD-L1 [Tumor Proportion Score (TPS) >= 1%", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "Keytruda (pembrolizumab)" + }, + { + "id": 138, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS >=1%) as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 [Tumor Proportion Score (TPS) >=1%], as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy. The product label further states that patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.", + "raw_biomarkers": "PD-L1 [Tumor Proportion Score (TPS) >= 1%", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Keytruda (pembrolizumab)" + }, + { + "id": 139, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) >=1] as determined by an FDA-approved test.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) >=1] as determined by an FDA-approved test.", + "raw_biomarkers": "PD-L1 [Combined Positive Score (CPS)] >= 1%", + "raw_cancer_type": "metastatic or unresectable, recurrent HNSCC", + "raw_therapeutics": "Keytruda (pembrolizumab)" + }, + { + "id": 140, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.", + "raw_biomarkers": "MSI-H or dMMR", + "raw_cancer_type": "unresectable or metastatic ... solid tumors", + "raw_therapeutics": "Keytruda (pembrolizumab)" + }, + { + "id": 141, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC), as determined by an FDA-approved test.", + "raw_biomarkers": "MSI-H or dMMR", + "raw_cancer_type": "unresectable or metastatic ... colorectal cancer", + "raw_therapeutics": "Keytruda (pembrolizumab)" + }, + { + "id": 142, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.", + "initial_approval_date": "2023-11-16", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125514s143lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab in combination with trastuzumab, fluoropyrimidine-, and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS >=1), as determined by an FDA-approved test. The product label notes that this indication is approved under accelerated approval based on tumor response rate and durability of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This indication is based on KEYNOTE-811 (NCT03615326), a multicenter, randomized, double-blind, placebo-controlled trial where patients received investigator's choice of chemotherapy between either cisplatin and 5-fu, or oxaliplatin and capecitabine.", + "raw_biomarkers": "HER2-positive... whose tumors express PD-L1 (CPS >= 1)", + "raw_cancer_type": "locally advanced unresectable or metastatic ... gastric or gastroesophageal junction (GEJ) adenocracinoma", + "raw_therapeutics": "Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy" + }, + { + "id": 143, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. This indication is based on KEYNOTE-859 (NCT03675737), a multicenter, randomized, double-blind, placebo-controlled trial where patients received investigator's choice of combination chemotherapy of either cisplatin and 5-fu or oxaliplatin and capecitabine.", + "raw_biomarkers": "HER2-negative", + "raw_cancer_type": "locally advanced unresectable or metastatic ... gastric or gastroesophageal junction (GEJ) adenocarcinoma", + "raw_therapeutics": "Keytruda (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy" + }, + { + "id": 144, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS >=10) as determined by an FDA-approved test.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS >=10), as determined by an FDA-approved test.", + "raw_biomarkers": "PD-L1 (CPS >= 10)", + "raw_cancer_type": "locally advanced or metastatic esophageal or gastroesophageal junction carcinoma", + "raw_therapeutics": "Keytruda (pembrolizumab)" + }, + { + "id": 145, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with chemotherapy with or without bevacizumab for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1), as determined by an FDA-approved test. This indication is based on KEYNOTE-826 (NCT03635567), a multicenter, randomized, double-blind, placebo-controlled trial where patients received one of the following as the chemotherapy portion of their treatment regimen: cisplatin and paclitaxel; bevacizumab, cisplatin, and paclitaxel; carboplatin and paclitaxel; bevacizumab, carboplatin, and paclitaxel.", + "raw_biomarkers": "PD-L1 (CPS >= 1)", + "raw_cancer_type": "persistent, recurrent, or metastatic cervical cancer", + "raw_therapeutics": "Keytruda (pembrolizumab) in combination with chemotherapy and with or without bevacizumab" + }, + { + "id": 146, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >=1), as determined by an FDA-approved test.", + "raw_biomarkers": "PD-L1 (CPS >= 1)", + "raw_cancer_type": "recurrent or metastatic cervical cancer", + "raw_therapeutics": "Keytruda (pembrolizumab)" + }, + { + "id": 147, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with lenvatinib for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.", + "raw_biomarkers": "pMMR or not MSI-H", + "raw_cancer_type": "advanced endometrial carcinoma", + "raw_therapeutics": "Keytruda (pembrolizumab) in combination with lenvatinib" + }, + { + "id": 148, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of patients with advanced endometrial carcinoma that is mismatch repair deficient (MMRd) or microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.", + "raw_biomarkers": "MSI-H or dMMR", + "raw_cancer_type": "advanced endometrial carcinoma", + "raw_therapeutics": "Keytruda (pembrolizumab)" + }, + { + "id": 149, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [>=10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [>=10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The product label states that the safety and effectiveness of pembrolizumab in pediatric patients with TMB-H central nervous system cancers have not been established and that this indication is approved under accelerated approval based on tumor response rate and durability of response. Furthermore, it states that continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.", + "raw_biomarkers": "TMB-H [>= 10 mutations / megabase]", + "raw_cancer_type": "unresectable or metastatic ... solid tumors", + "raw_therapeutics": "Keytruda (pembrolizumab)" + }, + { + "id": 150, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with chemotherapy for the neoadjuvant treatment, and then pembrolizumab continued as a single agent as adjuvant treatment after surgery, of patients with high-risk early-stage triple negative breast cancer (TNBC). This indication is based on KEYNOTE-522 (NCT03036488), a randomized (2:1), multicenter, double-blind, placebo-controlled trial where the chemotherapy regimen consisted of carboplatin, paclitaxel, doxorubicin, and cyclophosphamide.", + "raw_biomarkers": "triple-negative", + "raw_cancer_type": "high-risk early-stage triple-negative breast cancer", + "raw_therapeutics": "Keytruda (pembrolizumab) in combination with chemotherapy" + }, + { + "id": 151, + "document_id": 63, + "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS >=10) as determined by an FDA approved test.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (CPS >= 10), as determined by an FDA approved test. This indication is based on KEYNOTE-355 (NCT02819518), a multicenter, double-blind, randomized, placebo-controlled trial where patients received either paclitaxel and paclitaxel protein-bound, or gemcitabine and carboplatin.", + "raw_biomarkers": "triple-negative, PD-L1 (CPS >= 10)", + "raw_cancer_type": "locally recurrent unresectable or metastatic triple-negative breast cancer", + "raw_therapeutics": "Keytruda (pembrolizumab) in combination with chemotherapy" + }, + { + "id": 152, + "document_id": 64, + "indication": "PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "initial_approval_date": "2020-04-17", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to pemigatinib for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement, as detected by an FDA-approved test. The product label states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "raw_biomarkers": "FGFR2 fusion or other rearrangement", + "raw_cancer_type": "unresectable locally advanced or metastatic cholangiocarcinoma", + "raw_therapeutics": "Pemazyre (pemigatinib)" + }, + { + "id": 153, + "document_id": 64, + "indication": "PEMAZYRE is a kinase inhibitor indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.", + "initial_approval_date": "2022-08-26", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213736s002lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to pemigatinib for the treatment of adult patients with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.", + "raw_biomarkers": "FGFR1 rearrangement", + "raw_cancer_type": "relapsed or refractory myeloid/lymphoid neoplasms (MLNs)", + "raw_therapeutics": "Pemazyre (pemigatinib)" + }, + { + "id": 154, + "document_id": 65, + "indication": "PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.", + "initial_approval_date": "2012-06-08", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125409lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to pertuzumab in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "metastatic breast cancer", + "raw_therapeutics": "Perjeta (pertuzumab) in combination with trastuzumab and docetaxel" + }, + { + "id": 155, + "document_id": 65, + "indication": "PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.", + "initial_approval_date": "2017-12-20", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on Berenice (NCT02132949), a two-arm randomized study where HER2-positive was defined as a score of 3+ IHC or ISH amplification ratio of 2.0 or greater, as determined by a central laboratory. Patients received two potential chemotherapy regimens as part of the combination therapy: cyclophosphamide, doxorubicin, and paclitaxel; or cyclophosphamide, docetaxel, epirubicin, and 5-fu.", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "early stage breast cancer", + "raw_therapeutics": "Perjeta (pertuzumab) in combination with trastuzumab and chemotherapy" + }, + { + "id": 156, + "document_id": 65, + "indication": "PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.", + "initial_approval_date": "2017-12-20", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on Aphinity (NCT01358877) a multicenter, randomized, double-blind, placebo-controlled study where patients received one of the following anthracycline-based or non-anthracycline-based chemotherapy regimens: (1) cyclophosphamide, epirubicin, docetaxel, 5-fu; (2) cyclophosphamide, epirubicin, paclitaxel, 5-fu; (3) cyclophosphamide, doxorubicin, docetaxel, 5-fu; (4) cyclophosphamide, doxorubicin, paclitaxel, 5-fu; (5) doxorubicin, cyclophosphamide, docetaxel; (6) epirubicin, cyclophosphamide, docetaxel; (7) doxorubicin, cyclophosphamide, paclitaxel; (8) epirubicin, cyclophosphamide, paclitaxel; (9) carboplatin, docetaxel.", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "early stage breast cancer", + "raw_therapeutics": "Perjeta (pertuzumab) in combination with trastuzumab and chemotherapy" + }, + { + "id": 157, + "document_id": 66, + "indication": "PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.", + "initial_approval_date": "2020-06-29", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to Phesgo (pertuzumab and trastuzumab) in combination with chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on Berenice (NCT02132949), a two-arm randomized study where HER2-positive was defined as a score of 3+ IHC or ISH amplification ratio of 2.0 or greater, as determined by a central laboratory. Patients received two potential chemotherapy regimens as part of the combination therapy: cyclophosphamide, doxorubicin, and paclitaxel; or cyclophosphamide, docetaxel, epirubicin, and 5-fu. The FeDeriCa study (NCT03493854) demonstrated comparable pharmacokinetics and safety profiles between Phesgo and intravenous pertuzumab and intravenous trastuzumab.", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "early breast cancer", + "raw_therapeutics": "Phesgo (pertuzumab and trastuzumab) in combination with chemotherapy" + }, + { + "id": 158, + "document_id": 66, + "indication": "PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.", + "initial_approval_date": "2020-06-29", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to Phesgo (pertuzumab and trastuzumab) in combination with chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on Aphinity (NCT01358877) a multicenter, randomized, double-blind, placebo-controlled study where patients received one of the following anthracycline-based or non-anthracycline-based chemotherapy regimens: (1) cyclophosphamide, epirubicin, docetaxel, 5-fu; (2) cyclophosphamide, epirubicin, paclitaxel, 5-fu; (3) cyclophosphamide, doxorubicin, docetaxel, 5-fu; (4) cyclophosphamide, doxorubicin, paclitaxel, 5-fu; (5) doxorubicin, cyclophosphamide, docetaxel; (6) epirubicin, cyclophosphamide, docetaxel; (7) doxorubicin, cyclophosphamide, paclitaxel; (8) epirubicin, cyclophosphamide, paclitaxel; (9) carboplatin, docetaxel. The FeDeriCa study (NCT03493854) demonstrated comparable pharmacokinetics and safety profiles between Phesgo and intravenous pertuzumab and intravenous trastuzumab.", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "early breast cancer", + "raw_therapeutics": "Phesgo (pertuzumab and trastuzumab) in combination with chemotherapy" + }, + { + "id": 159, + "document_id": 66, + "indication": "PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with docetaxel for treatment of patients with HER2 positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.", + "initial_approval_date": "2020-06-29", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to Phesgo (pertuzumab and trastuzumab) in combination with docetaxel for the treatment of patients with HER2 positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "metastatic breast cancer", + "raw_therapeutics": "Phesgo (pertuzumab and trastuzumab) in combination with docetaxel" + }, + { + "id": 160, + "document_id": 67, + "indication": "ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed Ph+ ALL, in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).", + "initial_approval_date": "2024-03-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to ponatinib in combination with chemotherapy for the treatment of adult patients with newly diagnosed philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The product label notes that this indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction and that continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). This indication is based on PhALLCON (NCT03589326), a randomized, active-controlled, multicenter, open-label trial in which chemotherapy regimens were: vincristine and dexamethasone (induction, cycles 1 to 3); methotrexate and cytarabine (consolidation, cycles 4 to 9, alternating methotrexate and cytarabine); and vincristine and prednisone (maintenance, cycles 10 to 20).", + "raw_biomarkers": "Ph+", + "raw_cancer_type": "Ph+ ALL", + "raw_therapeutics": "Iclusig (ponatinib) in combination with chemotherapy" + }, + { + "id": 161, + "document_id": 67, + "indication": "ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with as monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL.", + "initial_approval_date": "2024-03-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ponatinib for the treatment of adult patients with philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL.", + "raw_biomarkers": "Ph+ and T315I", + "raw_cancer_type": "Ph+ ALL", + "raw_therapeutics": "Iclusig (ponatinib)" + }, + { + "id": 162, + "document_id": 67, + "indication": "ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase). Limitations of Use: ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.", + "initial_approval_date": "2016-11-28", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ponatinib for the treatment of adult patients with T315I-positive chronic myeloid leukemia (CML) in chronic phase, accelerated phase, or blast phase. The product label states the following limitations of use: ponatinib is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.", + "raw_biomarkers": "T315I-positive", + "raw_cancer_type": "CML", + "raw_therapeutics": "Iclusig (ponatinib)" + }, + { + "id": 163, + "document_id": 68, + "indication": "GAVRETO is a kinase inhibitor indicated for treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).", + "initial_approval_date": "2023-08-09", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213721s009lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to pralsetinib for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, as detected by an FDA approved test (NSCLC).", + "raw_biomarkers": "RET fusion-positive", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "Gavreto (pralsetinib)" + }, + { + "id": 164, + "document_id": 68, + "indication": "GAVRETO is a kinase inhibitor indicated for treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).", + "initial_approval_date": "2021-11-10", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213721s004lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to pralsetinib for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). The product label notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). This indication is based on ARROW (NCT03037385), a multicenter, open-label, multi-cohort clinical trial where all enrolled patients had papillary thyroid cancer.", + "raw_biomarkers": "RET fusion-positive", + "raw_cancer_type": "advanced or metastatic... thyroid cancer", + "raw_therapeutics": "Gavreto (pralsetinib)" + }, + { + "id": 165, + "document_id": 69, + "indication": "CYRAMZA is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated in combination with erlotinib, for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.", + "initial_approval_date": "2020-05-29", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125477s034lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ramucirumab in combination with erlotinib for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.", + "raw_biomarkers": "EGFR exon 19 deletions or exon 21 (L858R)", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Cyramza (ramucirumab) in combination with erlotinib" + }, + { + "id": 166, + "document_id": 70, + "indication": "AUGTYRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).", + "initial_approval_date": "2023-11-15", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218213s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).", + "raw_biomarkers": "ROS1-positive", + "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer", + "raw_therapeutics": "Augtyro (repotrectinib)" + }, + { + "id": 167, + "document_id": 70, + "indication": "AUGTYRO is a kinase inhibitor indicated for the treatment of adult and pedatric patients 12 years of age and older with solid tumors that (i) have a neutrophic tyrosine receptor kinase (NTRK) gene fusion and (ii) are locally advanced or metastatic or where surgical resection is likely to result in severe morbility, and (iii) have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "initial_approval_date": "2024-06-13", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218213s001lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to repotrectinib for the treatment of adult and pedatric patients 12 years of age and older with solid tumors that (i) have a neutrophic tyrosine receptor kinase (NTRK) gene fusion and (ii) are locally advanced or metastatic or where surgical resection is likely to result in severe morbility, and (iii) have progressed following treatment or have no satisfactory alternative therapy. The product label notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "raw_biomarkers": "NTRK gene fusions", + "raw_cancer_type": "solid tumors", + "raw_therapeutics": "Augtyro (repotrectinib)", + "date_regular_approval": "", + "date_accelerated_approval": "2024-06-13" + }, + { + "id": 168, + "document_id": 71, + "indication": "KISQALI is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy.", + "initial_approval_date": "2021-12-10", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s008lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ribociclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This indication is based on MONALEESA-2 (NCT01958021) and MONALEESA-7 (NCT02278120), where either anastrozole or letrozole were chosen for aromatase inhibiton.", + "raw_biomarkers": "HR-positive, HER2-negative", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Kisqali (ribociclib) in combination with an aromatase inhibitor" + }, + { + "id": 169, + "document_id": 71, + "indication": "KISQALI is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.", + "initial_approval_date": "2021-12-10", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s008lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ribociclib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as either an initial endocrine-based therapy or following disease progression on endocrine therapy.", + "raw_biomarkers": "HR-positive, HER2-negative", + "raw_cancer_type": "advanced or metastatic breast cancer", + "raw_therapeutics": "Kisqali (ribociclib) in combination with fulvestrant" + }, + { + "id": 170, + "document_id": 72, + "indication": "RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with relapsed or refractory, low grade or follicular, CD20-positive B- cell NHL as a single agent.", + "initial_approval_date": "2018-04-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5453lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to rituximab for the treatment of adult patients with relapsed or refractory, low grade or follicular, CD20-positive B-cell Non-Hodgkin's Lymphoma (NHL).", + "raw_biomarkers": "CD20-positive", + "raw_cancer_type": "B-cell Non-Hodgkin's Lymphoma (NHL)", + "raw_therapeutics": "Rituxan (rituximab)" + }, + { + "id": 171, + "document_id": 72, + "indication": "RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma (NHL) in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.", + "initial_approval_date": "2018-04-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5453lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to rituximab for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma (NHL) in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. This indication is based on 3 randomized, controlled trials that enrolled 1,662 patients where patients received either CVP (cyclophosphamide, vincristine, and prednisolone), CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), or FCM (cyclophosphamide, fludarabine, mitoxantrone).", + "raw_biomarkers": "CD20-positive", + "raw_cancer_type": "B-cell Non-Hodgkin's Lymphoma (NHL)", + "raw_therapeutics": "Rituxan (rituximab) in combination with chemotherapy" + }, + { + "id": 172, + "document_id": 72, + "indication": "RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL) non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.", + "initial_approval_date": "2018-04-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5453lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to rituximab for the treatment of adult patients with non-progressing (including stable disease), low-grade, CD20 positive, B-cell Non-Hodgkin's Lymphoma (NHL) as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.", + "raw_biomarkers": "CD20 positive", + "raw_cancer_type": "Non-Hodgkin's Lymphoma (NHL)", + "raw_therapeutics": "Rituxan (rituximab)" + }, + { + "id": 173, + "document_id": 72, + "indication": "RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL) previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.", + "initial_approval_date": "2018-04-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5453lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to rituximab in combination with CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other anthracycline-based chemotherapy regimens for the treatment of adult patients with previously untreated diffuse large B-cell, CD20-positive Non-Hodgkin's Lymphoma (NHL). This indication is based on three randomized, active-controlled, open-label, multicenter studies with a collective enrolled of 1854 patients. The product label did not specify the name of the clinical trial name (Study 9) that administered an anthracycline-containing chemotherapy regimen, or what the specific regimen was.", + "raw_biomarkers": "CD20-positive", + "raw_cancer_type": "diffuse large B-cell Non-Hodgkin's Lymhpoma (NHL)", + "raw_therapeutics": "Rituxan (rituximab) in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens." + }, + { + "id": 174, + "document_id": 72, + "indication": "RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy.", + "initial_approval_date": "2021-12-02", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5465lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to rituximab in combination with chemotherapy for the treatment of pediatric patients aged 6 months and older with previously untreated, advanced state, CD20-positive: diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). This indication is based on three randomized, active-controlled, open-label, multicenter studies with a collective enrollment of 1854 patients where patients received either CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other anthracycline-based chemotherapy regimens.", + "raw_biomarkers": "CD20-positive", + "raw_cancer_type": "mature B-cell NHL and mature B-cell acute leukemia (B-AL) previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL)", + "raw_therapeutics": "Rituxan (rituximab) in combination with chemotherapy" + }, + { + "id": 175, + "document_id": 72, + "indication": "RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive Chronic Lymphocytic Leukemia (CLL).", + "initial_approval_date": "2018-04-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5453lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to rituximab in combination with fludarabine and cyclophosphamide for the treatment of previously untreated and previously treated CD20-positive Chronic Lymphocytic Leukemia (CLL).", + "raw_biomarkers": "CD20-positive", + "raw_cancer_type": "Chronic Lymphocytic Leuekmia (CLL)", + "raw_therapeutics": "Rituxan (rituximab) in combination with fludarabine and cyclophosphamide (FC)" + }, + { + "id": 176, + "document_id": 73, + "indication": "RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.", + "initial_approval_date": "2018-04-06", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209115s003lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to rucaparib for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.", + "raw_biomarkers": "deleterious BRCA mutation (germline and/or somatic)", + "raw_cancer_type": "epithelial ovarian, fallopian tube, or primary peritoneal cancer", + "raw_therapeutics": "Rubraca (rucaparib)" + }, + { + "id": 177, + "document_id": 73, + "indication": "RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "initial_approval_date": "2020-05-15", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209115s004lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to rucaparib for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for rucaparib. Furthermore, it states that this indication is approved under accelerated approval based on objective response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "raw_biomarkers": "deleterious BRCA mutation (germline and/or somatic)", + "raw_cancer_type": "metastatic castration-resistant prostate cancer", + "raw_therapeutics": "Rubraca (rucaparib)" + }, + { + "id": 178, + "document_id": 74, + "indication": "TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.", + "initial_approval_date": "2021-04-07", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to sacituzumab govitecan for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.", + "raw_biomarkers": "triple-negative breast cancer", + "raw_cancer_type": "unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC)", + "raw_therapeutics": "Trodelvy (sacituzumab govitecan)" + }, + { + "id": 179, + "document_id": 74, + "indication": "TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.", + "initial_approval_date": "2023-02-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761115s035lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to sacituzumab govitecan for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.", + "raw_biomarkers": "HR-positive, HER2-negative (HC 0, IHC 1+, or IHC 2+/ISH-)", + "raw_cancer_type": "locally advanced or metastatic ... breast cancer", + "raw_therapeutics": "Trodelvy (sacituzumab govitecan)" + }, + { + "id": 180, + "document_id": 75, + "indication": "RETEVMO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.", + "initial_approval_date": "2020-05-08", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213246s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to selpercatinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.", + "raw_biomarkers": "RET fusion", + "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer", + "raw_therapeutics": "Retevmo (selpercatinib)", + "date_regular_approval": "", + "date_accelerated_approval": "2020-05-08" + }, + { + "id": 181, + "document_id": 75, + "indication": "RETEVMO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.", + "initial_approval_date": "2024-05-29", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to selpercatinib for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.", + "raw_biomarkers": "RET mutation", + "raw_cancer_type": "advanced or metastatic medullary thyroid cancer", + "raw_therapeutics": "Retevmo (selpercatinib)", + "date_regular_approval": "2024-09-27", + "date_accelerated_approval": "2024-05-29" + }, + { + "id": 182, + "document_id": 75, + "indication": "RETEVMO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).", + "initial_approval_date": "2024-05-29", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to selpercatinib for the treatment of treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).", + "raw_biomarkers": "RET gene fusion", + "raw_cancer_type": "advanced or metastatic thyroid cancer", + "raw_therapeutics": "Retevmo (selpercatinib)", + "date_regular_approval": "2024-06-12", + "date_accelerated_approval": "2024-05-29" + }, + { + "id": 183, + "document_id": 75, + "indication": "RETEVMO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).", + "initial_approval_date": "2022-09-21", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213246s007lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to selpercatinib for the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. The product label states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).", + "raw_biomarkers": "RET gene fusion", + "raw_cancer_type": "locally advanced or metastatic solid tumors", + "raw_therapeutics": "Retevmo (selpercatinib)", + "date_regular_approval": "", + "date_accelerated_approval": "2022-09-21" + }, + { + "id": 184, + "document_id": 76, + "indication": "LUMAKRAS is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "initial_approval_date": "2021-05-28", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214665s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to sotorasib for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. The product label states that this indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "raw_biomarkers": "KRAS G12C", + "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer", + "raw_therapeutics": "Lumakras (sotorasib)" + }, + { + "id": 185, + "document_id": 77, + "indication": "TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.", + "initial_approval_date": "2018-10-16", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to talazoparib for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for Talazoparib.", + "raw_biomarkers": "deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative", + "raw_cancer_type": "locally advanced or metastatic breast cancer", + "raw_therapeutics": "Talzenna (talazoparib)" + }, + { + "id": 186, + "document_id": 77, + "indication": "TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).", + "initial_approval_date": "2023-06-20", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211651s010lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to talazoparib in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).", + "raw_biomarkers": "HRR gene-mutated", + "raw_cancer_type": "metastatic castration-resistant prostate cancer", + "raw_therapeutics": "Talzenna (talazoparib) in combination with enzalutamide" + }, + { + "id": 187, + "document_id": 78, + "indication": "TAZVERIK is a methyltransferase inhibitor indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "initial_approval_date": "2023-11-16", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211723s004lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to tazemetostat for the treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved test, and who have received at least 2 prior systemic therapies. The product label states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "raw_biomarkers": "EZH2 mutation positive", + "raw_cancer_type": "follicular lymphoma", + "raw_therapeutics": "Tazverik (tazemetostat)" + }, + { + "id": 188, + "document_id": 79, + "indication": "TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.", + "initial_approval_date": "2021-02-03", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214096s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.", + "raw_biomarkers": "MET exon 14 skipping alterations", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "Tepmetko (tepotinib)", + "date_regular_approval": "2024-02-15", + "date_accelerated_approval": "2021-02-03" + }, + { + "id": 189, + "document_id": 80, + "indication": "MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naive patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to trametinib for the treatment of BRAF-inhibitor treatment-naive patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.", + "raw_biomarkers": "BRAF V600E or V600K", + "raw_cancer_type": "unresectable or metastatic melanoma", + "raw_therapeutics": "Mekinist (trametinib)" + }, + { + "id": 190, + "document_id": 80, + "indication": "MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to trametinib in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.", + "raw_biomarkers": "BRAF V600E or V600K", + "raw_cancer_type": "unresectable or metastatic melanoma", + "raw_therapeutics": "Mekinist (trametinib) in combination with dabrafenib" + }, + { + "id": 191, + "document_id": 80, + "indication": "MEKINIST is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to trametinib in combination with dabrafenib for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.", + "raw_biomarkers": "BRAF V600E or V600K", + "raw_cancer_type": "melanoma", + "raw_therapeutics": "Mekinist (trametinib) in combination with dabrafenib" + }, + { + "id": 192, + "document_id": 80, + "indication": "MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to trametinib in combination with dabrafenib for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Mekinist (trametinib) in combination with dabrafenib" + }, + { + "id": 193, + "document_id": 80, + "indication": "MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to trametinib in combination with dabrafenib for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "locally advanced or metastatic anaplastic thyroid cancer", + "raw_therapeutics": "Mekinist (trametinib) in combination with dabrafenib" + }, + { + "id": 194, + "document_id": 80, + "indication": "MEKINIST is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Limitations of Use: MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted accelerated approval to trametinib in combination with dabrafenib for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. The product label specifies that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Furthermore, the product label states a Limitation of Use: trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "unresectable or metastatic solid tumors", + "raw_therapeutics": "Mekinist (trametinib) in combination with dabrafenib" + }, + { + "id": 195, + "document_id": 80, + "indication": "MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.", + "initial_approval_date": "", + "initial_approval_url": "", + "description": "The U.S. Food and Drug Administration granted approval to trametinib in combination with dabrafenib for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "low-grade glioma (LGG)", + "raw_therapeutics": "Mekinist (trametinib) i combination with dabrafenib" + }, + { + "id": 196, + "document_id": 81, + "indication": "Herceptin is a HER2/neu receptor antagonist indicated for the treatment of HER2 -overexpressing breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.", + "initial_approval_date": "2008-01-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103792s5175lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to trastuzumab for the treatment of patients with HER2-overexpressing breast cancer. The product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for herceptin.", + "raw_biomarkers": "HER2-overexpressing", + "raw_cancer_type": "breast cancer", + "raw_therapeutics": "Herceptin (trastuzumab)" + }, + { + "id": 197, + "document_id": 81, + "indication": "Herceptin is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin.", + "initial_approval_date": "2010-10-20", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to trastuzumab for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab.", + "raw_biomarkers": "HER2-overexpressing", + "raw_cancer_type": "metastatic gastric or gastroesophageal junction adenocarcinoma", + "raw_therapeutics": "Herceptin (trastuzumab)" + }, + { + "id": 198, + "document_id": 82, + "indication": "ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either (i) in the metastatic setting, or (ii) in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.", + "initial_approval_date": "2022-05-04", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s017s020lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either (i) in the metastatic setting, or (ii) in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.", + "raw_biomarkers": "HER2-positive (IHC 3+ or ISH positive)", + "raw_cancer_type": "unresectable or metastatic breast cancer", + "raw_therapeutics": "Enhertu (trastuzumab deruxtecan)", + "date_regular_approval": "2022-05-04", + "date_accelerated_approval": "2019-12-20" + }, + { + "id": 199, + "document_id": 82, + "indication": "ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.", + "initial_approval_date": "2022-08-05", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s022lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to trastuzumab deruxtecan for the treatment of of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.", + "raw_biomarkers": "HER2-low (IHC 1+ or IHC2+/ISH-)", + "raw_cancer_type": "unresectable or metastatic ... breast cancer", + "raw_therapeutics": "Enhertu (trastuzumab deruxtecan)" + }, + { + "id": 200, + "document_id": 82, + "indication": "ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.", + "initial_approval_date": "2022-08-11", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s021lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. The product label states that these indications are approved under accelerated approval based on objective response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.", + "raw_biomarkers": "HER2 (ERBB2) mutations", + "raw_cancer_type": "unresectable or metastatic non-small cell lung cancer", + "raw_therapeutics": "Enhertu (trastuzumab deruxtecan)", + "date_regular_approval": "", + "date_accelerated_approval": "2022-08-11" + }, + { + "id": 201, + "document_id": 82, + "indication": "ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.", + "initial_approval_date": "2021-01-15", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761139s011lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to trastuzumab deruxtecan for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.", + "raw_biomarkers": "HER2-positive (IHC 3+ or IHC 2+/ISH positive)", + "raw_cancer_type": "locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma", + "raw_therapeutics": "Enhertu (trastuzumab deruxtecan)" + }, + { + "id": 202, + "document_id": 82, + "indication": "ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.", + "initial_approval_date": "2024-04-05", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761139s028lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. The product label states that this indication is approved under accelerated approval based on objective response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.", + "raw_biomarkers": "HER2-positive (IHC 3+)", + "raw_cancer_type": "unresectable or metastatic solid tumors", + "raw_therapeutics": "Enhertu (trastuzumab deruxtecan)", + "date_regular_approval": "", + "date_accelerated_approval": "2022-08-11" + }, + { + "id": 203, + "document_id": 83, + "indication": "IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.", + "initial_approval_date": "2022-11-10", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to tremelimumab-actl in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. This indication is based on POSEIDON (NCT03164616), a randomized, open-label, multicenter, active-controlled trial where patients received one of the following chemotherapy regimens: Pemetrexed in combination with carboplatin or cisplatin for patients with non-squamous NSCLC, gemcitabine with cisplatin or carboplatin for patients with squamous NSCLC, and nab-paclitaxel with carboplatin for either non-squamous or squamous NSCLC.", + "raw_biomarkers": "no sensitizing EGFR mutation or ALK genomic tumor aberrations", + "raw_cancer_type": "metastatic non-small cell lung cancer", + "raw_therapeutics": "Imjudo (tremelimumab-actl) in combination with durvalumab and platinum-based chemotherapy" + }, + { + "id": 204, + "document_id": 84, + "indication": "TUKYSA is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.", + "initial_approval_date": "2020-04-17", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213411s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.", + "raw_biomarkers": "HER2-positive", + "raw_cancer_type": "advanced unresectable or metastatic breast cancer", + "raw_therapeutics": "Tukysa (tucatinib) in combination with trastuzumab or capecitabine" + }, + { + "id": 205, + "document_id": 84, + "indication": "TUKYSA is a kinase inhibitor indicated in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "initial_approval_date": "2023-01-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213411s004lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to tucatinib in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The label notes that this indication is approved under accelerated approval based on tumor response rate and durability of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This indication is based on MOUNTAINEER (NCT03043313), an open-label, multicenter trial where RAS status was performed as standard of care prior to study entry based on expanded RAS testing including KRAS exons 2, 3, and 4 and NRAS exons 2, 3, and 4.", + "raw_biomarkers": "RAS wild-type, HER2-positive", + "raw_cancer_type": "unresectable or metastatic colorectal cancer", + "raw_therapeutics": "Tukysa (tucatinib) in combination with trastuzumab" + }, + { + "id": 206, + "document_id": 85, + "indication": "ZELBORAF is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.", + "initial_approval_date": "2011-08-17", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to vemurafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "unresectable or metastatic melanoma", + "raw_therapeutics": "Zelboraf (vemurafenib)" + }, + { + "id": 207, + "document_id": 85, + "indication": "ZELBORAF is indicated for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.", + "initial_approval_date": "2017-11-06", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s016lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to vemurafenib for the treatment of patients with Erdheim-Chester Disease and a BRAF V600 mutation.", + "raw_biomarkers": "BRAF V600", + "raw_cancer_type": "Erdheim-Chester Disease", + "raw_therapeutics": "Zelboraf (vemurafenib)" + }, + { + "id": 208, + "document_id": 60, + "indication": "TAGRISSO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.", + "initial_approval_date": "2024-09-25", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125514s143lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to osimertinib for the treatment of adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.", + "raw_biomarkers": "EGFR exon 19 deletions or exon 21 L858R", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "osimertinib" + }, + { + "id": 209, + "document_id": 7, + "indication": "RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.", + "initial_approval_date": "2024-08-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s003lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to amivantamab-vmjw in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.", + "raw_biomarkers": "EGFR exon 19 deletions or exon 21 L858R", + "raw_cancer_type": "locally advanced or metastatic non-small cell lung cancer", + "raw_therapeutics": "Rybrevant (amivantamab-vmjw) in combination with lazertinib" + }, + { + "id": 210, + "document_id": 86, + "indication": "LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.", + "initial_approval_date": "2024-08-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219008s000lbledt.pdf", + "description": "The U.S. Food and Drug Administration granted approval to lazertinib in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.", + "raw_biomarkers": "EGFR exon 19 deletions or exon 21 L858R", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "lazertinib in combination with amivantamab" + }, + { + "id": 211, + "document_id": 7, + "indication": "RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.", + "initial_approval_date": "2024-09-19", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s004lbl.pdf", + "description": "The U.S. Food and Drug administration granted approval to amivantamab-vmjw in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.", + "raw_biomarkers": "EGFR exon 19 deletions or exon 21 L858R", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "amivantamab in combination with carboplatin and pemetrexed" + }, + { + "id": 212, + "document_id": 87, + "indication": "ELAHERE is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FR-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.", + "initial_approval_date": "2024-03-22", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761310Origs005lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to mirvetuximab soravtansine-gynx for the treatment of adult patients with folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. The package insert states to select patients for therapy based on an FDA-approved test and, furthermore, that folate receptor-alpha tumor positive is defined as the presence of folate receptor-alpha tumor expression.", + "raw_biomarkers": "folate receptor-alpha tumor expression", + "raw_cancer_type": "epithelial ovarian, fallopian tube, or primary peritoneal", + "raw_therapeutics": "mirvetuximab soravtansine-gynx" + }, + { + "id": 213, + "document_id": 88, + "indication": "OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.", + "initial_approval_date": "2024-04-23", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to tovorafenib for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The product label states that this indication is approved under accelerated approval based on response rate and duration of response and furthermore that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "raw_biomarkers": "BRAF fusion or rearrangement, or BRAF V600 mutation", + "raw_cancer_type": "low-grade glioma (LGG)", + "raw_therapeutics": "tovorafenib", + "date_regular_approval": "", + "date_accelerated_approval": "2024-04-23" + }, + { + "id": 214, + "document_id": 29, + "indication": "IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.", + "initial_approval_date": "2024-08-15", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s043lbledt.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to durvalumab in combination with platinum-containing chemotherapy for the neoadjuvant treatment, followed by durvalumab as a single agent as adjuvant treatment after surgery, of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. This indication is based on AEGEAN\n(NCT03800134), a randomized, double-blind, placebo-controlled, multicenter trial where the choice of platinum-containing chemotherapy was dependent on tumor histology. Specifically, patients with squamous tumor histology received either carboplatin with paclitaxel or cisplatin with gemcitabine, and patients with non-squamous tumor histology received either pemetrexed with carboplatin or pemetrexed with cisplatin.", + "raw_biomarkers": "no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "durvalumab in combination with platinum-containing chemotherapy" + }, + { + "id": 215, + "document_id": 2, + "indication": "KRAZATI is an inhibitor of the RAS GTPase family indicated in combination with cetuximab for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of a clinical benefit in confirmatory trials.", + "initial_approval_date": "2024-06-21", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216340s005lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to adagrasib in combination with cetuximab for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The product label notes that this indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) and that continued approval for this indications may be contingent upon verification and description of a clinical benefit in confirmatory trials.", + "raw_biomarkers": "KRAS G12C", + "raw_cancer_type": "colorectal cancer", + "raw_therapeutics": "Krazati (adagrasib) in combination with cetuximab", + "date_regular_approval": "", + "date_accelerated_approval": "2024-06-21" + }, + { + "id": 216, + "document_id": 89, + "indication": "VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.", + "initial_approval_date": "2024-08-06", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) has granted approval to vorasidenib for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.", + "raw_biomarkers": "IDH1 or IDH2 mutations", + "raw_cancer_type": "astrocytoma or oligodendroglioma", + "raw_therapeutics": "vorasidenib" + }, + { + "id": 217, + "document_id": 71, + "indication": "KISQALI is a kinase inhibitor indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.", + "initial_approval_date": "2024-09-17", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf", + "description": "The U.S. Food and Drug Administration granted approval to ribociclib in combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. This indication is based on NATALEE (NCT03701334) was a randomized (1:1), open-label, multicenter study, where participants received goserelin and either letrozole or anastrozole, in addition to ribociclib.", + "raw_biomarkers": "hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative", + "raw_cancer_type": "early breast cancer", + "raw_therapeutics": "ribociclib in combination with an aromatase inhibitor" + }, + { + "id": 218, + "document_id": 57, + "indication": "OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>= 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab.", + "initial_approval_date": "2020-05-15", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s080lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to nivolumab in combination with ipilimumab for the first-line treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>= 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.", + "raw_biomarkers": "PD-L1 (>= 1%)", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "nivolumab in combination with ipilimumab" + }, + { + "id": 219, + "document_id": 57, + "indication": "OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy.", + "initial_approval_date": "2020-05-26", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s082lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to nivolumab in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This indication is based on CHECKMATE-9LA (NCT03215706), a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.", + "raw_biomarkers": "no EGFR or ALK genomic tumor aberrations", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "nivolumab in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy" + }, + { + "id": 220, + "document_id": 57, + "indication": "OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as a single agent or in combination with ipilimumab. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "initial_approval_date": "2018-07-10", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s063lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab as a single agent or in combination with ipilimumab for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan containing chemotherapy. The product label states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "raw_biomarkers": "microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)", + "raw_cancer_type": "colorectal cancer", + "raw_therapeutics": "nivolumab as a single agent or in combination with ipilimumab", + "date_regular_approval": "", + "date_accelerated_approval": "2018-07-10" + }, + { + "id": 221, + "document_id": 90, + "indication": "ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.", + "initial_approval_date": "2024-10-10", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219249s000lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to inavolisib in combination with palbociclib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.", + "raw_biomarkers": "PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative", + "raw_cancer_type": "metastatic breast cancer", + "raw_therapeutics": "inavolisib in combination with palbociclib and fulvestrant" + }, + { + "id": 222, + "document_id": 91, + "indication": "VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.", + "initial_approval_date": "2024-10-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761365s000lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to zolbetuximab in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive, as determined by an FDA-approved test. The package insert states that that eligible patients should have CLDN18.2 positive tumors, defined as >= 75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining. The package insert further states that this indication is based on Spotlight (8951-CL-0301) and Glow (8951-CL-0302), both phase 3, double-blind, randomized, multicenter studies that enrolled 1072 patients where the choice of either mFOLFOX6 (oxaliplatin, folinic acid, and fluorouracil) or CAPOX (oxaliplatin and capecitabine).", + "raw_biomarkers": "human epidermal growth factor receptor 2 (HER2)-negative .. claudin (CLDN) 18.2 positive", + "raw_cancer_type": "gastric or gastroesophageal junction adenocarcinoma", + "raw_therapeutics": "zolbetuximab in combination with fluoropyrimidine- and platinum-containing chemotherapy" + }, + { + "id": 223, + "document_id": 92, + "indication": "ZIHERA is a bispecific HER2-directed antibody indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "initial_approval_date": "2024-11-20", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761416Orig1s000Lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to zanitdatamab for the treatment of adult patients with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. The package insert states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "raw_biomarkers": "HER2-positive (IHC 3+)", + "raw_cancer_type": "biliary tract cancer (BTC)", + "raw_therapeutics": "zanidatamab", + "date_regular_approval": "", + "date_accelerated_approval": "2024-11-20" + }, + { + "id": 224, + "document_id": 93, + "indication": "BIZENGRI is a bispecific HER2- and HER3-directed antibody indicated for the treatment of adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "initial_approval_date": "2024-12-04", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761352s001lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to zenocutuzumab for the treatment of adult patients with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. The package insert notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "raw_biomarkers": "NGR1 gene fusion", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "zenocutuzumab-zbco", + "date_regular_approval": "", + "date_accelerated_approval": "2024-12-04" + }, + { + "id": 225, + "document_id": 93, + "indication": "BIZENGRI is a bispecific HER2- and HER3-directed antibody indicated for the treatment of adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "initial_approval_date": "2024-12-04", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761352s001lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to zenocutuzumab for the treatment of adult patients with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. The package insert notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).", + "raw_biomarkers": "NRG1 gene fusion", + "raw_cancer_type": "pancreatic adenocarcinoma", + "raw_therapeutics": "zenocutuzumab-zbco", + "date_regular_approval": "", + "date_accelerated_approval": "2024-12-04" + }, + { + "id": 226, + "document_id": 94, + "indication": "ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.", + "initial_approval_date": "2024-12-18", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218171s000lbl.pdf", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to ensartinib for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.", + "raw_biomarkers": "ALK-positive", + "raw_cancer_type": "non-small cell lung cancer", + "raw_therapeutics": "ensartinib" + }, + { + "id": 227, + "document_id": 32, + "indication": "BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.", + "initial_approval_date": "2024-12-20", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s017lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to encorafenib in combination with cetuximab and mFOLFOX6 for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. The package insert states that this indication is approved under accelerated approval based on response rate and durability of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Furthermore, it states that encorafenib's package insert further states that it is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF non-small cell lung cancer.", + "raw_biomarkers": "BRAF V600E", + "raw_cancer_type": "metastatic colorectal cancer ", + "raw_therapeutics": "Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6" + }, + { + "id": 228, + "document_id": 9, + "indication": "SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).", + "initial_approval_date": "2024-10-29", + "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf", + "description": "The U.S. Food and Drug Administration granted accelerated approval to asciminib for the treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). The package insert states that this indication is approved under accelerated approval based on major molecular response rate and that continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).", + "raw_biomarkers": "philadelphia chromosome-positive", + "raw_cancer_type": "philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)", + "raw_therapeutics": "Scemblix (asciminib)" + } +] \ No newline at end of file diff --git a/referenced/organizations.json b/referenced/organizations.json new file mode 100644 index 0000000..1e3a676 --- /dev/null +++ b/referenced/organizations.json @@ -0,0 +1,9 @@ +[ + { + "id": 0, + "label": "Food and Drug Administration", + "description": "Regulatory agency that approves drugs for use in the United States.", + "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", + "last_updated": "2025-01-10" + } +] \ No newline at end of file diff --git a/referenced/propositions.json b/referenced/propositions.json new file mode 100644 index 0000000..6c227c6 --- /dev/null +++ b/referenced/propositions.json @@ -0,0 +1,11022 @@ +[ + { + "id": 0, + "type": "VariantTherapeuticResponseProposition", + "predicate": "predictSensitivityTo", + "label": "", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. 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176, + "biomarkers": [ + 49 + ], + "conditionQualifier_id": 54, + "therapies": [ + 136 + ], + "objectTherapeutic": "", + "subjectVariant": "" + }, + { + "id": 468, + "type": "VariantTherapeuticResponseProposition", + "predicate": "predictSensitivityTo", + "label": "", + "description": "The U.S. Food and Drug Administration granted approval to rucaparib for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.", + "indication_id": 176, + "biomarkers": [ + 50 + ], + "conditionQualifier_id": 54, + "therapies": [ + 136 + ], + "objectTherapeutic": "", + "subjectVariant": "" + }, + { + "id": 469, + "type": "VariantTherapeuticResponseProposition", + "predicate": "predictSensitivityTo", + "label": "", + "description": "The U.S. Food and Drug Administration granted accelerated approval to 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U.S. Food and Drug Administration granted approval to selpercatinib for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.", + "indication_id": 181, + "biomarkers": [ + 152 + ], + "conditionQualifier_id": 38, + "therapies": [ + 78 + ], + "objectTherapeutic": "", + "subjectVariant": "" + }, + { + "id": 479, + "type": "VariantTherapeuticResponseProposition", + "predicate": "predictSensitivityTo", + "label": "", + "description": "The U.S. Food and Drug Administration granted accelerated approval to selpercatinib for the treatment of treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).", + 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"Targeted therapy" + }, + { + "id": 57, + "therapy_name": "Sotorasib", + "therapy_strategy": "RAS inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 58, + "therapy_name": "Futibatinib", + "therapy_strategy": "FGFR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 59, + "therapy_name": "Cyclophosphamide", + "therapy_strategy": "Alkylating chemotherapy", + "therapy_type": "Chemotherapy" + }, + { + "id": 60, + "therapy_name": "Rituximab", + "therapy_strategy": "CD20 inhibition", + "therapy_type": "Immunotherapy" + }, + { + "id": 61, + "therapy_name": "Vincristine", + "therapy_strategy": "Vinca alkaloid chemotherapy", + "therapy_type": "Chemotherapy" + }, + { + "id": 62, + "therapy_name": "Corticosteroid", + "therapy_strategy": "Anti-inflammatory", + "therapy_type": "Hormone therapy" + }, + { + "id": 63, + "therapy_name": "Cytarabine", + "therapy_strategy": "DNA Polymerase inhibition", + "therapy_type": "Chemotherapy" + }, + { + "id": 64, + "therapy_name": "Etoposide", + "therapy_strategy": "Topoisomerase inhibition", + "therapy_type": "Chemotherapy" + }, + { + "id": 65, + "therapy_name": "Methotrexate", + "therapy_strategy": "Antifolate", + "therapy_type": "Chemotherapy" + }, + { + "id": 66, + "therapy_name": "Trametinib", + "therapy_strategy": "MEK inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 67, + "therapy_name": "Dabrafenib", + "therapy_strategy": "B-RAF inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 68, + "therapy_name": "Daunorubicin", + "therapy_strategy": "DNA Polymerase inhibition", + "therapy_type": "Chemotherapy" + }, + { + "id": 69, + "therapy_name": "Gemtuzumab ozogamicin", + "therapy_strategy": "CD33 inhibition", + "therapy_type": "Immunotherapy" + }, + { + "id": 70, + "therapy_name": "Neratinib", + "therapy_strategy": "HER2 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 71, + "therapy_name": "Ipilimumab", + "therapy_strategy": "CTLA-4 inhibition", + "therapy_type": "Immunotherapy" + }, + { + "id": 72, + "therapy_name": "Nivolumab", + "therapy_strategy": "PD-1/PD-L1 inhibition", + "therapy_type": "Immunotherapy" + }, + { + "id": 73, + "therapy_name": "Relatlimab", + "therapy_strategy": "LAG-3 inhibition", + "therapy_type": "Immunotherapy" + }, + { + "id": 74, + "therapy_name": "Elacestrant", + "therapy_strategy": "ER signaling inhibition", + "therapy_type": "Hormone therapy" + }, + { + "id": 75, + "therapy_name": "Pertuzumab", + "therapy_strategy": "HER2 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 76, + "therapy_name": "Epirubicin", + "therapy_strategy": "Topoisomerase inhibition", + "therapy_type": "Chemotherapy" + }, + { + "id": 77, + "therapy_name": "Alpelisib", + "therapy_strategy": "PI3K/AKT/mTOR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 78, + "therapy_name": "Selpercatinib", + "therapy_strategy": "RET inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 79, + "therapy_name": "Lenalidomide", + "therapy_strategy": "Angiogenesis inhibition", + "therapy_type": "Chemotherapy" + }, + { + "id": 80, + "therapy_name": "Entrectinib", + "therapy_strategy": "ROS1 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 81, + "therapy_name": "Entrectinib", + "therapy_strategy": "TRK inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 82, + "therapy_name": "Midostaurin", + "therapy_strategy": "FLT3 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 83, + "therapy_name": "Asciminib", + "therapy_strategy": "BCR-ABL inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 84, + "therapy_name": "Dasatinib", + "therapy_strategy": "BCR-ABL inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 85, + "therapy_name": "Capmatinib", + "therapy_strategy": "MET inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 86, + "therapy_name": "Osimertinib", + "therapy_strategy": "EGFR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 87, + "therapy_name": "Talazoparib", + "therapy_strategy": "PARP inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 88, + "therapy_name": "Nilotinib", + "therapy_strategy": "BCR-ABL inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 89, + "therapy_name": "Atezolizumab", + "therapy_strategy": "PD-1/PD-L1 inhibition", + "therapy_type": "Immunotherapy" + }, + { + "id": 90, + "therapy_name": "Tepotinib", + "therapy_strategy": "MET inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 91, + "therapy_name": "Azacitidine", + "therapy_strategy": "Hypomethylating agent chemotherapy", + "therapy_type": "Chemotherapy" + }, + { + "id": 92, + "therapy_name": "Ivosidenib", + "therapy_strategy": "IDH1 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 93, + "therapy_name": "Arsenic trioxide", + "therapy_strategy": "PML::RARA inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 94, + "therapy_name": "Sacituzumab govitecan", + "therapy_strategy": "Topoisomerase inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 95, + "therapy_name": "Tucatinib", + "therapy_strategy": "HER2 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 96, + "therapy_name": "Lapatinib", + "therapy_strategy": "HER2 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 97, + "therapy_name": "Panitumumab", + "therapy_strategy": "EGFR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 98, + "therapy_name": "Venetoclax", + "therapy_strategy": "BCL2 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 99, + "therapy_name": "Abemaciclib", + "therapy_strategy": "CDK4/6 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 100, + "therapy_name": "Larotrectinib", + "therapy_strategy": "TRK inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 101, + "therapy_name": "Dacomitinib", + "therapy_strategy": "EGFR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 102, + "therapy_name": "Crizotinib", + "therapy_strategy": "ALK inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 103, + "therapy_name": "Crizotinib", + "therapy_strategy": "ROS1 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 104, + "therapy_name": "Gilteritinib", + "therapy_strategy": "FLT3 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 105, + "therapy_name": "Idelalisib", + "therapy_strategy": "PI3K/AKT/mTOR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 106, + "therapy_name": "Ceritinib", + "therapy_strategy": "ALK inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 107, + "therapy_name": "Tislelizumab", + "therapy_strategy": "PD-1/PD-L1 inhibition", + "therapy_type": "Immunotherapy" + }, + { + "id": 108, + "therapy_name": "Amivantamab", + "therapy_strategy": "EGFR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 109, + "therapy_name": "Capivasertib", + "therapy_strategy": "PI3K/AKT/mTOR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 110, + "therapy_name": "Erdafitinib", + "therapy_strategy": "FGFR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 111, + "therapy_name": "Zolbetuximab", + "therapy_strategy": "CLDN18.2 inhibition", + "therapy_type": "Immunotherapy" + }, + { + "id": 112, + "therapy_name": "Neratinib", + "therapy_strategy": "ER Signaling inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 113, + "therapy_name": "Zanubrutinib", + "therapy_strategy": "BTK inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 114, + "therapy_name": "Acalabrutinib", + "therapy_strategy": "BTK inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 115, + "therapy_name": "Ibrutinib", + "therapy_strategy": "BTK inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 116, + "therapy_name": "Ifosfamide", + "therapy_strategy": "Alkylating chemotherapy", + "therapy_type": "Chemotherapy" + }, + { + "id": 117, + "therapy_name": "Vinorelbine", + "therapy_strategy": "Vinca alkaloid chemotherapy", + "therapy_type": "Chemotherapy" + }, + { + "id": 118, + "therapy_name": "Doxorubicin", + "therapy_strategy": "Topoisomerase inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 119, + "therapy_name": "Tamoxifen", + "therapy_strategy": "Estrogen receptor inhibition", + "therapy_type": "Hormone therapy" + }, + { + "id": 120, + "therapy_name": "Ofatumumab", + "therapy_strategy": "CD20 inhibition", + "therapy_type": "Immunotherapy" + }, + { + "id": 121, + "therapy_name": "Bendamustine", + "therapy_strategy": "Alkylating chemotherapy", + "therapy_type": "Chemotherapy" + }, + { + "id": 122, + "therapy_name": "Prednisolone", + "therapy_strategy": "Corticosteroid", + "therapy_type": "Steroid" + }, + { + "id": 123, + "therapy_name": "Chlorambucil", + "therapy_strategy": "Alkylating chemotherapy", + "therapy_type": "Chemotherapy" + }, + { + "id": 124, + "therapy_name": "Mitoxantrone", + "therapy_strategy": "Topoisomerase inhibition", + "therapy_type": "Chemotherapy" + }, + { + "id": 125, + "therapy_name": "Interferon-alpha", + "therapy_strategy": "Cytokine stimulation", + "therapy_type": "Immunotherapy" + }, + { + "id": 126, + "therapy_name": "Enasidenib", + "therapy_strategy": "IDH2 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 127, + "therapy_name": "Infigratinib", + "therapy_strategy": "FGFR2 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 128, + "therapy_name": "Margetuximab-cmkb", + "therapy_strategy": "ER signaling inhibition", + "therapy_type": "Hormone therapy" + }, + { + "id": 129, + "therapy_name": "Eribulin", + "therapy_strategy": "Tubulin polymerization inhibition", + "therapy_type": "Chemotherapy" + }, + { + "id": 130, + "therapy_name": "Mobocertinib", + "therapy_strategy": "EGFR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 131, + "therapy_name": "Olutasidenib", + "therapy_strategy": "IDH1 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 132, + "therapy_name": "Lenvatinib", + "therapy_strategy": "VEGFR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 133, + "therapy_name": "Pemigatinib", + "therapy_strategy": "FGFR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 134, + "therapy_name": "Repotrectinib", + "therapy_strategy": "ROS inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 135, + "therapy_name": "Fludarabine", + "therapy_strategy": "Antimetabolite", + "therapy_type": "Chemotherapy" + }, + { + "id": 136, + "therapy_name": "Rucaparib", + "therapy_strategy": "PARP inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 137, + "therapy_name": "Tazemetostat", + "therapy_strategy": "EZH2 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 138, + "therapy_name": "Enzalutamide", + "therapy_strategy": "Antiandrogen", + "therapy_type": "Hormone therapy" + }, + { + "id": 139, + "therapy_name": "Lazertinib", + "therapy_strategy": "EGFR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 140, + "therapy_name": "Mirvetuximab soravtansine-gynx", + "therapy_strategy": "Folate receptor-alpha inhibition", + "therapy_type": "Chemotherapy" + }, + { + "id": 141, + "therapy_name": "Tovorafenib", + "therapy_strategy": "B-RAF inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 142, + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH1/2 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 143, + "therapy_name": "Goserelin", + "therapy_strategy": "Gonadotropin-releasing hormone (GnRH) agonist", + "therapy_type": "Hormone therapy" + }, + { + "id": 144, + "therapy_name": "Inavolisib", + "therapy_strategy": "PI3K/AKT/mTOR inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 145, + "therapy_name": "Zanidatamab", + "therapy_strategy": "ER signaling inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 146, + "therapy_name": "Zenocutuzumab", + "therapy_strategy": "NRG1 inhibition", + "therapy_type": "Targeted therapy" + }, + { + "id": 147, + "therapy_name": "Ensartinib", + "therapy_strategy": "ALK inhibition", + "therapy_type": "Targeted therapy" + } +] \ No newline at end of file From 5cee4a51c4c48fe6ddaf9d5990941f4e80ee1471 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Mon, 27 Jan 2025 12:13:09 -0500 Subject: [PATCH 02/22] Moved dereference script to utils dir --- dereference.py => utils/dereference.py | 0 1 file changed, 0 insertions(+), 0 deletions(-) rename dereference.py => utils/dereference.py (100%) diff --git a/dereference.py b/utils/dereference.py similarity index 100% rename from dereference.py rename to utils/dereference.py From 7bdded1c961aa323d2f416701d8fb7e70b1ca72f Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Tue, 28 Jan 2025 14:31:27 -0500 Subject: [PATCH 03/22] Added documentation to set up the virtualenv --- README.md | 31 +++++++++++++++++++++++++++++++ 1 file changed, 31 insertions(+) diff --git a/README.md b/README.md index 405c558..e4d93ac 100644 --- a/README.md +++ b/README.md @@ -11,6 +11,37 @@ If you wish to suggest an assertion for cataloging in this database, you can do - Suggesting an entry through our [web browser's form](https://moalmanac.org/add) - Suggesting an entry through our [Google Chrome extension](https://chrome.google.com/webstore/detail/molecular-oncology-almana/jliaipolchffpaccagodphgjpfdpcbcm) +# Installation +## Download +This repository can be downloaded through GitHub by either using the website or terminal. To download on the website, navigate to the top of this page, click the green `Clone or download` button, and select `Download ZIP` to download this repository in a compressed format. To install using GitHub on terminal, type + +```bash +git clone https://github.com/vanallenlab/moalmanac-db.git +cd moalmanac-db +``` + +### Python dependencies +This repository uses Python 3.12. We recommend using a [virtual environment](https://docs.python.org/3/tutorial/venv.html) and running Python with either [Anaconda](https://www.anaconda.com/download/) or [Miniconda](https://conda.io/miniconda.html). + +Run the following from this repository's directory to create a virtual environment and install dependencies with Anaconda or Miniconda, +```bash +conda create -y -n moalmanac-db python=3.12 +conda activate moalmanac-db +pip install -r requirements.txt +``` + +Or, if using base Python, +```bash +virtualenv venv +source activate venv/bin/activate +pip install -r requirements.txt +``` + +To make the virtual environment available to jupyter notebooks, execute the following code while the virtual environment is activated, +```bash +ipython kernel install --user --name=moalmanac-db +``` + ## Citation If you find this tool or any code herein useful, please cite: > [Reardon, B., Moore, N.D., Moore, N.S., *et al*. Integrating molecular profiles into clinical frameworks through the Molecular Oncology Almanac to prospectively guide precision oncology. *Nat Cancer* (2021). https://doi.org/10.1038/s43018-021-00243-3](https://www.nature.com/articles/s43018-021-00243-3) From 303cd9cae83bf05659710f03add625e109cce7d9 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Tue, 28 Jan 2025 14:35:19 -0500 Subject: [PATCH 04/22] Changed heading structure in README --- README.md | 12 ++++++------ 1 file changed, 6 insertions(+), 6 deletions(-) diff --git a/README.md b/README.md index e4d93ac..26acda2 100644 --- a/README.md +++ b/README.md @@ -11,9 +11,9 @@ If you wish to suggest an assertion for cataloging in this database, you can do - Suggesting an entry through our [web browser's form](https://moalmanac.org/add) - Suggesting an entry through our [Google Chrome extension](https://chrome.google.com/webstore/detail/molecular-oncology-almana/jliaipolchffpaccagodphgjpfdpcbcm) -# Installation -## Download -This repository can be downloaded through GitHub by either using the website or terminal. To download on the website, navigate to the top of this page, click the green `Clone or download` button, and select `Download ZIP` to download this repository in a compressed format. To install using GitHub on terminal, type +## Installation +### Download +This repository can be downloaded through GitHub by either using the website or terminal. To download on the website, navigate to the top of this page, click the green `Clone or download` button, and select `Download ZIP` to download this repository in a compressed format. To install using GitHub on terminal, type: ```bash git clone https://github.com/vanallenlab/moalmanac-db.git @@ -23,21 +23,21 @@ cd moalmanac-db ### Python dependencies This repository uses Python 3.12. We recommend using a [virtual environment](https://docs.python.org/3/tutorial/venv.html) and running Python with either [Anaconda](https://www.anaconda.com/download/) or [Miniconda](https://conda.io/miniconda.html). -Run the following from this repository's directory to create a virtual environment and install dependencies with Anaconda or Miniconda, +Run the following from this repository's directory to create a virtual environment and install dependencies with Anaconda or Miniconda: ```bash conda create -y -n moalmanac-db python=3.12 conda activate moalmanac-db pip install -r requirements.txt ``` -Or, if using base Python, +Or, if using base Python: ```bash virtualenv venv source activate venv/bin/activate pip install -r requirements.txt ``` -To make the virtual environment available to jupyter notebooks, execute the following code while the virtual environment is activated, +To make the virtual environment available to jupyter notebooks, execute the following code while the virtual environment is activated: ```bash ipython kernel install --user --name=moalmanac-db ``` From 0685b45c7928394d04fd084af449d00998033d7d Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Tue, 28 Jan 2025 17:34:35 -0500 Subject: [PATCH 05/22] Renamed function --- utils/dereference.py | 6 +++--- 1 file changed, 3 insertions(+), 3 deletions(-) diff --git a/utils/dereference.py b/utils/dereference.py index 984aa44..37a37f8 100644 --- a/utils/dereference.py +++ b/utils/dereference.py @@ -9,7 +9,7 @@ class Dereference: """ @staticmethod - def get_by_key_value(records: list[dict], value: typing.Any, key: str = "id", warn: bool = True) -> list[dict]: + def fetch_records_by_key_value(records: list[dict], value: typing.Any, key: str = "id", warn: bool = True) -> list[dict]: """ Retrieves records where a specific field matches a given value. @@ -53,7 +53,7 @@ def integer(cls, records: list[dict], referenced_key: str, referenced_records: l if not referenced_key in keys: raise KeyError(f"Key '{referenced_key}' not found in {record}.") - referenced_record = cls.get_by_key_value( + referenced_record = cls.fetch_records_by_key_value( records=referenced_records, key='id', value=record[referenced_key] @@ -94,7 +94,7 @@ def list(cls, records: list[dict], referenced_key: str, referenced_records: list _values = [] for value in record[referenced_key]: - _value = cls.get_by_key_value( + _value = cls.fetch_records_by_key_value( records=referenced_records, key='id', value=value From c9453428257efabc1cd5ccaa147513749ad588a7 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Tue, 28 Jan 2025 17:37:06 -0500 Subject: [PATCH 06/22] Changed output type in docstring for load_json function --- utils/dereference.py | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/utils/dereference.py b/utils/dereference.py index 37a37f8..4a4c7a9 100644 --- a/utils/dereference.py +++ b/utils/dereference.py @@ -135,7 +135,7 @@ def load_json(file: str) -> list[dict]: file (str): Path to the JSON file. Returns: - dict: Parsed data from the JSON file. + list[dict]: Parsed data from the JSON file. Raises: FileNotFoundError: If the file does not exist. From c614f9353430749983bf85e38c154be7e4a2f3e0 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Tue, 28 Jan 2025 17:41:22 -0500 Subject: [PATCH 07/22] Update utils/dereference.py Update description of Dereference.integer function per Sabrina's recommendation Co-authored-by: sabrinacamp2 <52207849+sabrinacamp2@users.noreply.github.com> --- utils/dereference.py | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/utils/dereference.py b/utils/dereference.py index 4a4c7a9..752809c 100644 --- a/utils/dereference.py +++ b/utils/dereference.py @@ -35,7 +35,7 @@ def fetch_records_by_key_value(records: list[dict], value: typing.Any, key: str @classmethod def integer(cls, records: list[dict], referenced_key: str, referenced_records: list[dict], new_key_name: str) -> list[dict]: """ - Dereferences a key for each record in records, presuming that the corresponding value is an integer. + Dereferences a key for each record in records, where the key's value references a single record (i.e. is an integer). Args: records (list[dict]): list of dictionaries that require a key to be dereferenced. From 017ffaf60ad19e23f3e0a475fa4ee3244e7813e3 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Tue, 28 Jan 2025 17:44:29 -0500 Subject: [PATCH 08/22] Update utils/dereference.py Argument description update in Dereference.integer function, recommended by Sabrina Co-authored-by: sabrinacamp2 <52207849+sabrinacamp2@users.noreply.github.com> --- utils/dereference.py | 4 ++-- 1 file changed, 2 insertions(+), 2 deletions(-) diff --git a/utils/dereference.py b/utils/dereference.py index 752809c..6303b30 100644 --- a/utils/dereference.py +++ b/utils/dereference.py @@ -39,9 +39,9 @@ def integer(cls, records: list[dict], referenced_key: str, referenced_records: l Args: records (list[dict]): list of dictionaries that require a key to be dereferenced. - referenced_key (str): name of the key in records to dereference. + referenced_key (str): name of the key in `records` to dereference. referenced_records (str): list of dictionaries that the referenced_key refers to. - new_key_name (str): name of the key in records to replace referenced_key after dereference. + new_key_name (str): key to store dereferenced record in `records`. this key replaces referenced_key. Raises: KeyError: If the referenced_key is not found in the record. From f436cd1c1578a0120a71b6f4f79a614875f964d9 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Tue, 28 Jan 2025 17:45:38 -0500 Subject: [PATCH 09/22] Updated args docstring in Dereference.integer function --- utils/dereference.py | 4 ++-- 1 file changed, 2 insertions(+), 2 deletions(-) diff --git a/utils/dereference.py b/utils/dereference.py index 6303b30..1630ac7 100644 --- a/utils/dereference.py +++ b/utils/dereference.py @@ -40,8 +40,8 @@ def integer(cls, records: list[dict], referenced_key: str, referenced_records: l Args: records (list[dict]): list of dictionaries that require a key to be dereferenced. referenced_key (str): name of the key in `records` to dereference. - referenced_records (str): list of dictionaries that the referenced_key refers to. - new_key_name (str): key to store dereferenced record in `records`. this key replaces referenced_key. + referenced_records (list[dict]): list of dictionaries that the referenced_key refers to. + new_key_name (str): key to store dereferenced record in `records`. this key replaces `referenced_key`. Raises: KeyError: If the referenced_key is not found in the record. From 2579c1a031bf1103d073752e545bd4b447f45968 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Tue, 28 Jan 2025 17:46:35 -0500 Subject: [PATCH 10/22] Update utils/dereference.py Updating description of Dereference.list function, as recommended by Sabrina Co-authored-by: sabrinacamp2 <52207849+sabrinacamp2@users.noreply.github.com> --- utils/dereference.py | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/utils/dereference.py b/utils/dereference.py index 1630ac7..365152a 100644 --- a/utils/dereference.py +++ b/utils/dereference.py @@ -73,7 +73,7 @@ def integer(cls, records: list[dict], referenced_key: str, referenced_records: l @classmethod def list(cls, records: list[dict], referenced_key: str, referenced_records: list[dict], key_always_present: bool = True) -> list[dict]: """ - Dereferences a key for each record in records, presuming that the corresponding value is a list. + Dereferences a key for each record in records, where the key's value can store multiple records (i.e. is a list). Args: records (list[dict]): list of dictionaries that require a key to be dereferenced. From b03f34eb163c40b4218cb33a85c1478856d8b09e Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Wed, 29 Jan 2025 09:47:56 -0500 Subject: [PATCH 11/22] Return dereferenced json in main function. Added docstring to main function. --- utils/dereference.py | 21 +++++++++++++++++---- 1 file changed, 17 insertions(+), 4 deletions(-) diff --git a/utils/dereference.py b/utils/dereference.py index 365152a..d04196d 100644 --- a/utils/dereference.py +++ b/utils/dereference.py @@ -156,9 +156,9 @@ def write_json_dict(data: dict, keys_list: list[str], file:str) -> None: Write json from input object of dictionary Args: - data (dict): A object of type dictionary, though one key value should be a list of dictionaries (records) + data (dict): A object of type dictionary, though one key value should be a list of dictionaries (records). keys_list (list[str]): A list of keys that are of type list[dict] (records). - file (str): The output file path + file (str): The output file path. Raises: TypeError: If the keys provided with keys_list are not a list of dictionaries. @@ -192,8 +192,8 @@ def write_json_records(data: list[dict], file:str) -> None: Writes json from input object of list[dict] Args: - data (list[dict]): A object of type list with elements as dictionaries - file (str): The output file path + data (list[dict]): A object of type list with elements as dictionaries. + file (str): The output file path. Raises: TypeError: If the input is not a list of dictionaries. @@ -221,6 +221,17 @@ def write_json_records(data: list[dict], file:str) -> None: def main(input_paths, output): + """ + Creates a single JSON file for the Molecular Oncology Almanac (moalmanac) database by dereferencing + referenced JSON files. By default, these are located in the referenced/ folder of this repository. + + Args: + input_paths (dict): Dictionary of paths to referenced JSON files. + output (str): The output file to write the dereferenced JSON to. + + Returns: + list[dict]: Dereferenced database. + """ about = load_json(file=input_paths['about']) agents = load_json(file=input_paths['agents']) biomarkers = load_json(file=input_paths['biomarkers']) @@ -326,6 +337,8 @@ def main(input_paths, output): file=output ) + return dereferenced + if __name__ =="__main__": arg_parser = argparse.ArgumentParser( From a10b6623ba814185af588a44a966c40ca96a0100 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Wed, 29 Jan 2025 09:48:17 -0500 Subject: [PATCH 12/22] Added README to utils directory. Wrote documentation for dereference.py. --- utils/README.md | 49 +++++++++++++++++++++++++++++++++++++++++++++++++ 1 file changed, 49 insertions(+) create mode 100644 utils/README.md diff --git a/utils/README.md b/utils/README.md new file mode 100644 index 0000000..e70f7d9 --- /dev/null +++ b/utils/README.md @@ -0,0 +1,49 @@ +# moalmanac-db utils +Utility scripts for use with the Molecular Oncology Almanac (moalmanac) database. + +**The default arguments for scripts in this directory assume that you are running them from the root directory of this repository.** + +# Table of contents +- [dereference.py](#dereferencepy) + +# Scripts +## dereference.py +`dereference.py` creates a single JSON file for the Molecular Oncology Almanac (moalmanac) database by dereferencing referenced JSON files. By default, these are located in the `referenced/` folder of this repository. + +### Usage +Optional arguments: +```bash + --about referenced JSON for database metadata. Default: referenced/about.json + --agents referenced JSON for agents contribution to database. Default: referenced/agents.json + --biomarkers referenced JSON for biomarkers. Default: referenced/biomarkers.json + --contributions referenced JSON for contributions to database. Default: referenced/contributions.json + --diseases referenced JSON for cancer types. Default: referenced/diseases.json + --documents referenced JSON for documents cited in the database. Default: referenced/documents.json + --genes referenced JSON for genes associated with biomarkers. Default: referenced/genes.json + --indications referenced JSON for regulatory approvals for use or reimbursement. Default: referenced/indications.json + --organizations referenced JSON for organizations that publish documents cited within the database. Default: referenced/organizations.json + --propositions referenced JSON for propositions. Default: referenced/propositions.json + --statements referenced JSON for statements. Default: referenced/statements.json + --therapies referenced JSON for therapies. Default: referenced/therapies.json + --output file path for dereferenced JSON output by this script. Default: moalmanac-draft.dereferenced.json +``` + +Example: +```bash +python dereference.py \ + --about referenced/about.json \ + --agents referenced/agents.json \ + --biomarkers referenced/biomarkers.json \ + --contributions referenced/contributions.json \ + --diseases referenced/diseases.json \ + --documents referenced/documents.json \ + --genes referenced/genes.json \ + --indications referenced/indications.json \ + --organizations referenced/organizations.json \ + --propositions referenced/propositions.json \ + --statements referenced/statements.json \ + --therapies referenced/therapies.json \ + --output moalmanac-draft.dereferenced.json +``` + +[Back to table of contents](#table-of-contents) \ No newline at end of file From 01aef8844fc15fd59f222012f24a55c8d86246a4 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Wed, 29 Jan 2025 13:33:51 -0500 Subject: [PATCH 13/22] Minor change to README --- utils/README.md | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/utils/README.md b/utils/README.md index e70f7d9..ae43035 100644 --- a/utils/README.md +++ b/utils/README.md @@ -8,7 +8,7 @@ Utility scripts for use with the Molecular Oncology Almanac (moalmanac) database # Scripts ## dereference.py -`dereference.py` creates a single JSON file for the Molecular Oncology Almanac (moalmanac) database by dereferencing referenced JSON files. By default, these are located in the `referenced/` folder of this repository. +`dereference.py` creates a single JSON file for the moalmanac database by dereferencing referenced JSON files. By default, these are located in the `referenced/` folder of this repository. ### Usage Optional arguments: From 3b0807aeb7738980dc3b3ea3c2013525894f40a1 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Wed, 29 Jan 2025 15:35:41 -0500 Subject: [PATCH 14/22] Added schema diagram --- docs/assets/README.md | 12 ++++++++++++ docs/assets/moalmanac-db-schema-diagram.svg | 1 + 2 files changed, 13 insertions(+) create mode 100644 docs/assets/README.md create mode 100644 docs/assets/moalmanac-db-schema-diagram.svg diff --git a/docs/assets/README.md b/docs/assets/README.md new file mode 100644 index 0000000..9ce7a62 --- /dev/null +++ b/docs/assets/README.md @@ -0,0 +1,12 @@ +# Documentation assets +The following assets are used by documentation within the `docs/` folder of this repository. + +# Table of contents +- [dereference.py](#dereferencepy) + +# Assets +## Database schema diagram +[moalmanac-db-schema-diagram.svg](moalmanac-db-schema-diagram.svg) is a diagram of the database schema. Here, we aim to highlight +1. Connections between the [different references between files that make up the database](../../references/) +2. What parts of our schema is represented within [GA4GH's va-spec](https://github.com/ga4gh/va-spec) +3. What parts of our schema are compliant with va-spec diff --git a/docs/assets/moalmanac-db-schema-diagram.svg b/docs/assets/moalmanac-db-schema-diagram.svg new file mode 100644 index 0000000..ce1fd9e --- /dev/null +++ b/docs/assets/moalmanac-db-schema-diagram.svg @@ -0,0 +1 @@ + \ No newline at end of file From 2b7f31c6169db193a44ff2f8b5e55c8d27932a76 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Wed, 29 Jan 2025 15:37:10 -0500 Subject: [PATCH 15/22] Added table of contents to documentation assets and url to database schema diagram --- docs/assets/README.md | 4 +++- 1 file changed, 3 insertions(+), 1 deletion(-) diff --git a/docs/assets/README.md b/docs/assets/README.md index 9ce7a62..ce33d02 100644 --- a/docs/assets/README.md +++ b/docs/assets/README.md @@ -2,7 +2,7 @@ The following assets are used by documentation within the `docs/` folder of this repository. # Table of contents -- [dereference.py](#dereferencepy) +- [Database schema diagram](#database-schema-diagram) # Assets ## Database schema diagram @@ -10,3 +10,5 @@ The following assets are used by documentation within the `docs/` folder of this 1. Connections between the [different references between files that make up the database](../../references/) 2. What parts of our schema is represented within [GA4GH's va-spec](https://github.com/ga4gh/va-spec) 3. What parts of our schema are compliant with va-spec + +This diagram was created with [Google Draw](https://docs.google.com/drawings/d/1fLOOwtc87YVEJfy4oTiP04cUFgKVGalv8vv4k0L__2c/edit?usp=sharing). From afe09b898ffa4cf04a281d8b0c1611a36df37bc8 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Wed, 29 Jan 2025 15:38:34 -0500 Subject: [PATCH 16/22] Trying to inline show assets within the README --- docs/assets/README.md | 6 +++++- 1 file changed, 5 insertions(+), 1 deletion(-) diff --git a/docs/assets/README.md b/docs/assets/README.md index ce33d02..aff68a0 100644 --- a/docs/assets/README.md +++ b/docs/assets/README.md @@ -6,9 +6,13 @@ The following assets are used by documentation within the `docs/` folder of this # Assets ## Database schema diagram -[moalmanac-db-schema-diagram.svg](moalmanac-db-schema-diagram.svg) is a diagram of the database schema. Here, we aim to highlight +[moalmanac-db-schema-diagram.svg](moalmanac-db-schema-diagram.svg) is a diagram of the database schema. Here, we aim to highlight: 1. Connections between the [different references between files that make up the database](../../references/) 2. What parts of our schema is represented within [GA4GH's va-spec](https://github.com/ga4gh/va-spec) 3. What parts of our schema are compliant with va-spec This diagram was created with [Google Draw](https://docs.google.com/drawings/d/1fLOOwtc87YVEJfy4oTiP04cUFgKVGalv8vv4k0L__2c/edit?usp=sharing). + +![moalmanac-db-schema-diagram.svg](moalmanac-db-schema-diagram.svg) + +[Back to table of contents](#table-of-contents) \ No newline at end of file From 1cbeaa57adca0200787a777946e7328304c37b3c Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Wed, 29 Jan 2025 16:03:10 -0500 Subject: [PATCH 17/22] Revised utils/README header and first section --- utils/README.md | 6 +++--- 1 file changed, 3 insertions(+), 3 deletions(-) diff --git a/utils/README.md b/utils/README.md index ae43035..d7431c2 100644 --- a/utils/README.md +++ b/utils/README.md @@ -1,7 +1,7 @@ -# moalmanac-db utils -Utility scripts for use with the Molecular Oncology Almanac (moalmanac) database. +# Utility scripts for the Molecular Oncology Almanac database +This directory contains a collection of utility scripts designed to facilitate the management and processing of the Molecular Oncology Almanac (moalmanac) database. -**The default arguments for scripts in this directory assume that you are running them from the root directory of this repository.** +**Note: The default arguments for scripts within this directory assume execution from the root directory of this repository.** # Table of contents - [dereference.py](#dereferencepy) From c0f0ca4871f70b8c1bc1b148d6b89f4e734d41ce Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Wed, 29 Jan 2025 16:44:57 -0500 Subject: [PATCH 18/22] Removed trailing spaces --- referenced/indications.json | 6 +- utils/dereference.py | 174 ++++-------------------------------- utils/json_utils.py | 141 +++++++++++++++++++++++++++++ 3 files changed, 161 insertions(+), 160 deletions(-) create mode 100644 utils/json_utils.py diff --git a/referenced/indications.json b/referenced/indications.json index 939fab2..a7f26f6 100644 --- a/referenced/indications.json +++ b/referenced/indications.json @@ -35,7 +35,7 @@ { "id": 3, "document_id": 0, - "indication": "Verzenio is a kinase inhibitor indicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. ", + "indication": "Verzenio is a kinase inhibitor indicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.", "initial_approval_date": "2017-09-28", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716Orig1s000lbl.pdf", "description": "The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.", @@ -679,7 +679,7 @@ { "id": 61, "document_id": 27, - "indication": "SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ", + "indication": "SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.", "initial_approval_date": "2018-12-21", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s021lbl.pdf", "description": "The U.S. Food and Drug Administration granted approval to dasatinib in combination with chemotherapy for the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).", @@ -1155,7 +1155,7 @@ "indication": "TYKERB is a kinase inhibitor indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use: Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.", "initial_approval_date": "2007-03-13", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059lbl.pdf", - "description": "The U.S. Food and Drug Administration granted approval to lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, a trastuzumab. ", + "description": "The U.S. Food and Drug Administration granted approval to lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, a trastuzumab.", "raw_biomarkers": "HER2 overexpression", "raw_cancer_type": "advanced or metastatic breast cancer", "raw_therapeutics": "Tykerb (lapatinib) in combination with capecitabine" diff --git a/utils/dereference.py b/utils/dereference.py index d04196d..3b7255f 100644 --- a/utils/dereference.py +++ b/utils/dereference.py @@ -1,6 +1,6 @@ import argparse -import json -import typing + +from . import json_utils class Dereference: @@ -8,30 +8,6 @@ class Dereference: Functions to dereference, depending on the field type to dereference """ - @staticmethod - def fetch_records_by_key_value(records: list[dict], value: typing.Any, key: str = "id", warn: bool = True) -> list[dict]: - """ - Retrieves records where a specific field matches a given value. - - Args: - records (list[dict]): A list of dictionaries to search. - value (any): The value to match. - key (str): The field to check (default: "id"). - warn (bool): Whether to warn and exit if the number of results is not 1 (default: True). - - Returns: - list[dict]: A list of matching records. - - Raises: - ValueError: If the number of results is not exactly 1 and warnings are enabled. - """ - results = [record for record in records if record.get(key) == value] - - if warn and len(results) != 1: - ValueError(f"Warning: Expected 1 result for {key} == {value}, found {len(results)}.") - - return results - @classmethod def integer(cls, records: list[dict], referenced_key: str, referenced_records: list[dict], new_key_name: str) -> list[dict]: """ @@ -53,7 +29,7 @@ def integer(cls, records: list[dict], referenced_key: str, referenced_records: l if not referenced_key in keys: raise KeyError(f"Key '{referenced_key}' not found in {record}.") - referenced_record = cls.fetch_records_by_key_value( + referenced_record = json_utils.fetch_records_by_key_value( records=referenced_records, key='id', value=record[referenced_key] @@ -94,7 +70,7 @@ def list(cls, records: list[dict], referenced_key: str, referenced_records: list _values = [] for value in record[referenced_key]: - _value = cls.fetch_records_by_key_value( + _value = json_utils.fetch_records_by_key_value( records=referenced_records, key='id', value=value @@ -104,122 +80,6 @@ def list(cls, records: list[dict], referenced_key: str, referenced_records: list return records - @staticmethod - def rename_key(dictionary: dict, old_key: str, new_key: str) -> None: - """ - Renames a key in a dictionary. - - Args: - dictionary (dict): The dictionary to modify. - old_key (str): The key to rename. - new_key (str): The new key name. - - Raises: - KeyError: If the old_key does not exist in the dictionary. - ValueError: If the new_key already exists in the dictionary. - """ - if old_key not in dictionary: - raise KeyError(f"Key '{old_key}' not found in the dictionary.") - - if new_key in dictionary: - raise ValueError(f"Key '{new_key}' already exists in the dictionary.") - - dictionary[new_key] = dictionary.pop(old_key) - - -def load_json(file: str) -> list[dict]: - """ - Loads and parses a JSON file. - - Args: - file (str): Path to the JSON file. - - Returns: - list[dict]: Parsed data from the JSON file. - - Raises: - FileNotFoundError: If the file does not exist. - json.JSONDecodeError: If the file contains invalid JSON. - """ - try: - with open(file, "r") as fp: - data = json.load(fp) - return data - except FileNotFoundError as e: - raise FileNotFoundError(f"File not found: {file}") from e - except json.JSONDecodeError as e: - raise json.JSONDecodeError(f"Invalid JSON in file: {file}", e.doc, e.pos) - - -def write_json_dict(data: dict, keys_list: list[str], file:str) -> None: - """ - Write json from input object of dictionary - - Args: - data (dict): A object of type dictionary, though one key value should be a list of dictionaries (records). - keys_list (list[str]): A list of keys that are of type list[dict] (records). - file (str): The output file path. - - Raises: - TypeError: If the keys provided with keys_list are not a list of dictionaries. - ValueError: If the JSON serialization fails. - """ - - if not isinstance(data, dict): - raise TypeError("The input data must be of type dict") - - for key in keys_list: - if not all(isinstance(item, dict) for item in data[key]): - raise TypeError(f"All elements in the list must be dictionaries for key {key}.") - - try: - # Serialize python object (data) to a JSON formatted string - json_object = json.dumps(data, indent=4) - except (TypeError, ValueError) as e: - raise ValueError(f"Failed to serialize the object to JSON: {e}") - - try: - # Write json string to the specified file - with open(file, "w") as outfile: - outfile.write(json_object) - print(f"JSON successfully written to {file}") - except IOError as e: - raise IOError(f"Failed to write to file {file}: {e}") - - -def write_json_records(data: list[dict], file:str) -> None: - """ - Writes json from input object of list[dict] - - Args: - data (list[dict]): A object of type list with elements as dictionaries. - file (str): The output file path. - - Raises: - TypeError: If the input is not a list of dictionaries. - ValueError: If the JSON serialization fails. - """ - if not isinstance(data, list): - raise TypeError("The input data must be of type list") - - if not all(isinstance(item, dict) for item in data): - raise TypeError("All elements in the list must be dictionaries.") - - try: - # Serialize python object (data) to a JSON formatted string - json_object = json.dumps(data, indent=4) - except (TypeError, ValueError) as e: - raise ValueError(f"Failed to serialize the object to JSON: {e}") - - try: - # Write json string to the specified file - with open(file, "w") as outfile: - outfile.write(json_object) - print(f"JSON successfully written to {file}") - except IOError as e: - raise IOError(f"Failed to write to file {file}: {e}") - - def main(input_paths, output): """ Creates a single JSON file for the Molecular Oncology Almanac (moalmanac) database by dereferencing @@ -232,18 +92,18 @@ def main(input_paths, output): Returns: list[dict]: Dereferenced database. """ - about = load_json(file=input_paths['about']) - agents = load_json(file=input_paths['agents']) - biomarkers = load_json(file=input_paths['biomarkers']) - contributions = load_json(file=input_paths['contributions']) - diseases = load_json(file=input_paths['diseases']) - documents = load_json(file=input_paths['documents']) - genes = load_json(file=input_paths['genes']) - indications = load_json(file=input_paths['indications']) - organizations = load_json(file=input_paths['organizations']) - propositions = load_json(file=input_paths['propositions']) - statements = load_json(file=input_paths['statements']) - therapies = load_json(file=input_paths['therapies']) + about = json_utils.load(file=input_paths['about']) + agents = json_utils.load(file=input_paths['agents']) + biomarkers = json_utils.load(file=input_paths['biomarkers']) + contributions = json_utils.load(file=input_paths['contributions']) + diseases = json_utils.load(file=input_paths['diseases']) + documents = json_utils.load(file=input_paths['documents']) + genes = json_utils.load(file=input_paths['genes']) + indications = json_utils.load(file=input_paths['indications']) + organizations = json_utils.load(file=input_paths['organizations']) + propositions = json_utils.load(file=input_paths['propositions']) + statements = json_utils.load(file=input_paths['statements']) + therapies = json_utils.load(file=input_paths['therapies']) # biomarkers; references genes.json dereferenced_biomarkers = Dereference.list( @@ -331,7 +191,7 @@ def main(input_paths, output): } # Write - write_json_dict( + json_utils.write_dict( data=dereferenced, keys_list=['content'], file=output diff --git a/utils/json_utils.py b/utils/json_utils.py new file mode 100644 index 0000000..a15b0f2 --- /dev/null +++ b/utils/json_utils.py @@ -0,0 +1,141 @@ +import json +import typing + + +def fetch_records_by_key_value(records: list[dict], value: typing.Any, key: str = "id", warn: bool = True) -> list[dict]: + """ + Retrieves records where a specific field matches a given value. + + Args: + records (list[dict]): A list of dictionaries to search. + value (any): The value to match. + key (str): The field to check (default: "id"). + warn (bool): Whether to warn and exit if the number of results is not 1 (default: True). + + Returns: + list[dict]: A list of matching records. + + Raises: + ValueError: If the number of results is not exactly 1 and warnings are enabled. + """ + results = [record for record in records if record.get(key) == value] + + if warn and len(results) != 1: + ValueError(f"Warning: Expected 1 result for {key} == {value}, found {len(results)}.") + + return results + + +def rename_key(dictionary: dict, old_key: str, new_key: str) -> None: + """ + Renames a key in a dictionary. + + Args: + dictionary (dict): The dictionary to modify. + old_key (str): The key to rename. + new_key (str): The new key name. + + Raises: + KeyError: If the old_key does not exist in the dictionary. + ValueError: If the new_key already exists in the dictionary. + """ + if old_key not in dictionary: + raise KeyError(f"Key '{old_key}' not found in the dictionary.") + + if new_key in dictionary: + raise ValueError(f"Key '{new_key}' already exists in the dictionary.") + + dictionary[new_key] = dictionary.pop(old_key) + + +def load(file: str) -> list[dict]: + """ + Loads and parses a JSON file. + + Args: + file (str): Path to the JSON file. + + Returns: + list[dict]: Parsed data from the JSON file. + + Raises: + FileNotFoundError: If the file does not exist. + json.JSONDecodeError: If the file contains invalid JSON. + """ + try: + with open(file, "r") as fp: + data = json.load(fp) + return data + except FileNotFoundError as e: + raise FileNotFoundError(f"File not found: {file}") from e + except json.JSONDecodeError as e: + raise json.JSONDecodeError(f"Invalid JSON in file: {file}", e.doc, e.pos) + + +def write_dict(data: dict, keys_list: list[str], file:str) -> None: + """ + Write json from input object of dictionary + + Args: + data (dict): A object of type dictionary, though one key value should be a list of dictionaries (records). + keys_list (list[str]): A list of keys that are of type list[dict] (records). + file (str): The output file path. + + Raises: + TypeError: If the keys provided with keys_list are not a list of dictionaries. + ValueError: If the JSON serialization fails. + """ + + if not isinstance(data, dict): + raise TypeError("The input data must be of type dict") + + for key in keys_list: + if not all(isinstance(item, dict) for item in data[key]): + raise TypeError(f"All elements in the list must be dictionaries for key {key}.") + + try: + # Serialize python object (data) to a JSON formatted string + json_object = json.dumps(data, indent=4) + except (TypeError, ValueError) as e: + raise ValueError(f"Failed to serialize the object to JSON: {e}") + + try: + # Write json string to the specified file + with open(file, "w") as outfile: + outfile.write(json_object) + print(f"JSON successfully written to {file}") + except IOError as e: + raise IOError(f"Failed to write to file {file}: {e}") + + +def write_records(data: list[dict], file:str) -> None: + """ + Writes json from input object of list[dict] + + Args: + data (list[dict]): A object of type list with elements as dictionaries. + file (str): The output file path. + + Raises: + TypeError: If the input is not a list of dictionaries. + ValueError: If the JSON serialization fails. + """ + if not isinstance(data, list): + raise TypeError("The input data must be of type list") + + if not all(isinstance(item, dict) for item in data): + raise TypeError("All elements in the list must be dictionaries.") + + try: + # Serialize python object (data) to a JSON formatted string + json_object = json.dumps(data, indent=4) + except (TypeError, ValueError) as e: + raise ValueError(f"Failed to serialize the object to JSON: {e}") + + try: + # Write json string to the specified file + with open(file, "w") as outfile: + outfile.write(json_object) + print(f"JSON successfully written to {file}") + except IOError as e: + raise IOError(f"Failed to write to file {file}: {e}") From 89194e0ca00e41315e3bf84d215375aafd7ac48e Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Wed, 29 Jan 2025 18:09:45 -0500 Subject: [PATCH 19/22] Added test for trailing spaces, resolved current failures --- referenced/indications.json | 2 +- referenced/propositions.json | 2 +- utils/test.py | 136 +++++++++++++++++++++++++++++++++++ utils/test_utils.py | 34 +++++++++ 4 files changed, 172 insertions(+), 2 deletions(-) create mode 100644 utils/test.py create mode 100644 utils/test_utils.py diff --git a/referenced/indications.json b/referenced/indications.json index a7f26f6..de892f4 100644 --- a/referenced/indications.json +++ b/referenced/indications.json @@ -2540,7 +2540,7 @@ "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s017lbl.pdf", "description": "The U.S. Food and Drug Administration granted accelerated approval to encorafenib in combination with cetuximab and mFOLFOX6 for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. The package insert states that this indication is approved under accelerated approval based on response rate and durability of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Furthermore, it states that encorafenib's package insert further states that it is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF non-small cell lung cancer.", "raw_biomarkers": "BRAF V600E", - "raw_cancer_type": "metastatic colorectal cancer ", + "raw_cancer_type": "metastatic colorectal cancer", "raw_therapeutics": "Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6" }, { diff --git a/referenced/propositions.json b/referenced/propositions.json index 6c227c6..bf93b73 100644 --- a/referenced/propositions.json +++ b/referenced/propositions.json @@ -4073,7 +4073,7 @@ "type": "VariantTherapeuticResponseProposition", "predicate": "predictSensitivityTo", "label": "", - "description": "The U.S. Food and Drug Administration granted approval to lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, a trastuzumab. ", + "description": "The U.S. Food and Drug Administration granted approval to lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, a trastuzumab.", "indication_id": 104, "biomarkers": [ 20 diff --git a/utils/test.py b/utils/test.py new file mode 100644 index 0000000..a182b87 --- /dev/null +++ b/utils/test.py @@ -0,0 +1,136 @@ +import unittest + +import json_utils +import test_utils + +class Base(unittest.TestCase): + @classmethod + def setUpClass(cls): + cls.input_paths = { + 'about': 'referenced/about.json', + 'agents': 'referenced/agents.json', + 'biomarkers': 'referenced/biomarkers.json', + 'contributions': 'referenced/contributions.json', + 'diseases': 'referenced/diseases.json', + 'documents': 'referenced/documents.json', + 'genes': 'referenced/genes.json', + 'indications': 'referenced/indications.json', + 'organizations': 'referenced/organizations.json', + 'propositions': 'referenced/propositions.json', + 'statements': 'referenced/statements.json', + 'therapies': 'referenced/therapies.json' + } + + # Load all JSON data once for use in tests + cls.data = {} + for key, value in cls.input_paths.items(): + cls.data[key] = json_utils.load(file=value) + + +class TestDataIntegrity(Base): + def test_url_matches_document(self): + # Logic to check if URL within citation matches the document URL + pass + + def test_publication_date_consistency(self): + # Logic to ensure publication date in citation matches publication date field + pass + + def test_no_mismatch_between_document_and_statement(self): + # Logic to check for mismatches between documents in indications and statements + pass + + def test_missing_id_values(self): + # Logic to check for missing ID values + pass + + +class TestDateConsistency(Base): + def test_accessed_date_vs_publication_date(self): + # Logic to ensure accessed date is equal to or more recent than publication date + pass + + def test_last_updated_vs_first_published(self): + # Logic to check if last_updated dates come before first published dates + pass + + def test_document_access_date(self): + # Logic to ensure document access date is earlier than first published + pass + + +class TestFormatting(Base): + def test_ending_periods(self): + # Logic to ensure all indications and descriptions end with periods + pass + + def test_spelling_errors(self): + # Logic to print all strings and value counts to look for misspellings + pass + + def test_trailing_spaces(self): + # Logic to check for trailing spaces in indications or descriptions + tests = [ + # tuples of file (records; list[dict]) and key for each record in records + # the key should be present in each record + ('agents', 'label'), + ('biomarkers', 'label'), + ('contributions', 'description'), + ('diseases', 'label'), + ('documents', 'access_date'), + ('documents', 'citation'), + ('documents', 'company'), + ('documents', 'drug_name_brand'), + ('documents', 'drug_name_generic'), + ('documents', 'drug_name_generic'), + ('documents', 'first_published'), + ('documents', 'label'), + ('documents', 'publication_date'), + ('documents', 'url'), + ('documents', 'url_drug'), + ('genes', 'label'), + ('indications', 'indication'), + ('indications', 'initial_approval_date'), + ('indications', 'initial_approval_url'), + ('indications', 'description'), + ('indications', 'raw_biomarkers'), + ('indications', 'raw_cancer_type'), + ('indications', 'raw_therapeutics'), + ('organizations', 'label'), + ('organizations', 'last_updated'), + ('organizations', 'description'), + ('organizations', 'url'), + ('propositions', 'description'), + ('statements', 'direction'), + ('statements', 'evidence'), + ('therapies', 'therapy_name'), + ('therapies', 'therapy_strategy'), + ('therapies', 'therapy_type') + ] + + for record_type, key in tests: + with self.subTest(record_type=record_type, key=key): + failed_records = test_utils.Test.find_trailing_spaces(records=self.data[record_type], key=key) + if failed_records: + failed_record_ids = ", ".join(str(failed_record) for failed_record in failed_records) + self.fail( + f"Trailing spaces detected.\n" + f" - File: {record_type}\n" + f" - Key: {key}\n" + f" - Affected IDs: {failed_record_ids}\n" + f" - Total affected: {len(failed_records)}" + ) + + def test_utf8_characters(self): + # Logic to search for non-standard UTF-8 characters + pass + + +class TestReferenceOrdering(unittest.TestCase): + def test_order_by_alphabetic_labels(self): + # Logic to ensure therapy and biomarkers are in alphabetical order + pass + + +if __name__ == '__main__': + unittest.main() diff --git a/utils/test_utils.py b/utils/test_utils.py new file mode 100644 index 0000000..fdb5bda --- /dev/null +++ b/utils/test_utils.py @@ -0,0 +1,34 @@ +class Common: + @staticmethod + def has_trailing_spaces(string: str) -> bool: + """ + Checks if a string has trailing spaces. + + Args: + string (str): The string to check. + + Returns: + bool: True if the string has trailing spaces, False otherwise. + """ + return string != string.rstrip() + + +class Test: + + @staticmethod + def find_trailing_spaces(records, key): + """ + Identifies if any value associated with `key` contains trailing spaces for each record in `records`. + + Args: + records (list[dict]): list of dictionaries. + key (str): The key to look for trailing spaces, required for each record in records. + + Returns: + failed_records (list[dict]): list of failed records, returning only the `id` and `key` that failed. + """ + failed_records = [] + for record in records: + if Common.has_trailing_spaces(record[key]): + failed_records.append(record['id']) + return failed_records From 398c56dd8ca8bcfb349d430b0d0e8328025cb5d3 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Wed, 29 Jan 2025 21:33:17 -0500 Subject: [PATCH 20/22] Test for url and url within citation matching --- referenced/documents.json | 2 +- utils/test.py | 30 +++++++++++++++++++++++++++--- 2 files changed, 28 insertions(+), 4 deletions(-) diff --git a/referenced/documents.json b/referenced/documents.json index 0d0da43..49601f9 100644 --- a/referenced/documents.json +++ b/referenced/documents.json @@ -1031,7 +1031,7 @@ "subtype": "Regulatory approval", "label": "Opdivo (nivolumab) [package insert]. U.S. FDA.", "alternativeLabels": [], - "citation": "Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125527s000lbl.pdf. Revised October 2024. Accessed October 30, 2024.", + "citation": "Bristol-Myers Squibb Company. Opdivo (nivolumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s127lbl.pdf. Revised October 2024. Accessed October 30, 2024.", "company": "Bristol-Myers Squibb Company.", "drug_name_brand": "Opdivo", "drug_name_generic": "nivolumab", diff --git a/utils/test.py b/utils/test.py index a182b87..5f047b8 100644 --- a/utils/test.py +++ b/utils/test.py @@ -6,6 +6,9 @@ class Base(unittest.TestCase): @classmethod def setUpClass(cls): + """ + Import json files from referenced/ and make them available to inherited test classes + """ cls.input_paths = { 'about': 'referenced/about.json', 'agents': 'referenced/agents.json', @@ -29,8 +32,25 @@ def setUpClass(cls): class TestDataIntegrity(Base): def test_url_matches_document(self): - # Logic to check if URL within citation matches the document URL - pass + """ + Assess if `url` field matches the url contained in the `citation` for documents where the url should be + contained within the citation.Currently, this is relevant for documents where the subtype is one of the + following: + - Regulatory approval + """ + relevant_subtypes = [ + 'Regulatory approval' + ] + relevant_records = [record for record in self.data['documents'] if record['subtype'] in relevant_subtypes] + with self.subTest(): + failed_records = [record for record in relevant_records if record['url'] not in record['citation']] + if failed_records: + failed_record_ids = ", ".join(str(record['id']) for record in failed_records) + self.fail( + f"URL mismatch between url key value and url contained within citation detected.\n" + f" - Affected ID(s): {failed_record_ids}\n" + f" - Total affected: {len(failed_records)}" + ) def test_publication_date_consistency(self): # Logic to ensure publication date in citation matches publication date field @@ -69,6 +89,10 @@ def test_spelling_errors(self): pass def test_trailing_spaces(self): + """ + Assess if any values have trailing spaces in any of the json key pairs + """ + # Logic to check for trailing spaces in indications or descriptions tests = [ # tuples of file (records; list[dict]) and key for each record in records @@ -117,7 +141,7 @@ def test_trailing_spaces(self): f"Trailing spaces detected.\n" f" - File: {record_type}\n" f" - Key: {key}\n" - f" - Affected IDs: {failed_record_ids}\n" + f" - Affected ID(s): {failed_record_ids}\n" f" - Total affected: {len(failed_records)}" ) From d19c4d531c45f056693696fa0c0cb64b92eda50b Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Wed, 29 Jan 2025 21:50:02 -0500 Subject: [PATCH 21/22] Resolved document mismatch between statements and indications --- referenced/statements.json | 2 +- utils/test.py | 39 +++++++++++++++++++++++++++++++------- 2 files changed, 33 insertions(+), 8 deletions(-) diff --git a/referenced/statements.json b/referenced/statements.json index 4f93f92..97ae943 100644 --- a/referenced/statements.json +++ b/referenced/statements.json @@ -656,7 +656,7 @@ 0 ], "reportedIn": [ - 14 + 13 ], "proposition_id": 50, "direction": "supports", diff --git a/utils/test.py b/utils/test.py index 5f047b8..55af0a6 100644 --- a/utils/test.py +++ b/utils/test.py @@ -31,7 +31,7 @@ def setUpClass(cls): class TestDataIntegrity(Base): - def test_url_matches_document(self): + def test_document_url_matches_citation(self): """ Assess if `url` field matches the url contained in the `citation` for documents where the url should be contained within the citation.Currently, this is relevant for documents where the subtype is one of the @@ -52,13 +52,34 @@ def test_url_matches_document(self): f" - Total affected: {len(failed_records)}" ) - def test_publication_date_consistency(self): - # Logic to ensure publication date in citation matches publication date field - pass + def test_no_mismatch_between_document_for_indication_and_statement(self): + """ + Assess if document associated with indications and associated statements differ + While statement['reportedIn'] is of type list, + """ - def test_no_mismatch_between_document_and_statement(self): - # Logic to check for mismatches between documents in indications and statements - pass + with self.subTest(): + for statement in self.data['statements']: + statement_documents = statement['reportedIn'] + proposition = json_utils.fetch_records_by_key_value( + records=self.data['propositions'], + key='id', + value=statement['proposition_id'] + ) + proposition = proposition[0] + + indication = json_utils.fetch_records_by_key_value( + records=self.data['indications'], + key='id', + value=proposition['indication_id'] + ) + indication = indication[0] + + if indication['document_id'] not in statement_documents: + self.fail( + f"Document ID mismatch between indication and statement detected.\n" + f" - Affected ID(s): statement {statement['id']} and indication {indication['id']}" + ) def test_missing_id_values(self): # Logic to check for missing ID values @@ -78,6 +99,10 @@ def test_document_access_date(self): # Logic to ensure document access date is earlier than first published pass + def test_publication_date_consistency(self): + # Logic to ensure publication date in citation matches publication date field + pass + class TestFormatting(Base): def test_ending_periods(self): From d79ab712d9e5b21b5d376dfd4bb38cb1fe66e934 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Thu, 30 Jan 2025 08:33:05 -0500 Subject: [PATCH 22/22] Test to ensure indications and descriptions end with periods --- referenced/indications.json | 16 +++---- utils/test.py | 87 +++++++++++++++++++++++++++++-------- 2 files changed, 78 insertions(+), 25 deletions(-) diff --git a/referenced/indications.json b/referenced/indications.json index de892f4..4822edd 100644 --- a/referenced/indications.json +++ b/referenced/indications.json @@ -57,7 +57,7 @@ { "id": 5, "document_id": 2, - "indication": "KRAZATI is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s)", + "indication": "KRAZATI is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).", "initial_approval_date": "2022-12-12", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216340Orig1s000Corrected_lbl.pdf", "description": "The U.S. Food and Drug Administration granted accelerated approval to adagrasib for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA approved test, who have received at least one prior systemic therapy. The product label notes that this indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR), and that continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).", @@ -73,7 +73,7 @@ "indication": "KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease; or developed disease recurrence during or within six months of completing adjuvant therapy. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA.", "initial_approval_date": "2013-02-22", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf", - "description": "The U.S. Food and Drug Administration granted approval to ado-trastuzumab emtansine", + "description": "The U.S. Food and Drug Administration granted approval to ado-trastuzumab emtansine.", "raw_biomarkers": "HER2-positive", "raw_cancer_type": "metastatic breast cancer", "raw_therapeutics": "Kadcyla (ado-trastuzumab emtansine)" @@ -473,7 +473,7 @@ "indication": "ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy.", "initial_approval_date": "2012-07-06", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s225lbl.pdf", - "description": "The U.S. Food and Drug Administration granted approval to cetuximab in combination with irinotecan for the treatment of patients with K-Ras wild-type, EGFR-expressing metastatic colorectal", + "description": "The U.S. Food and Drug Administration granted approval to cetuximab in combination with irinotecan for the treatment of patients with K-Ras wild-type, EGFR-expressing metastatic colorectal.", "raw_biomarkers": "K-Ras wild-type, EGFR-expressing", "raw_cancer_type": "metastatic colorectal cancer", "raw_therapeutics": "Erbitux (cetuximab) in combination with irinotecan" @@ -525,7 +525,7 @@ { "id": 47, "document_id": 24, - "indication": "XALKORI is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL", + "indication": "XALKORI is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.", "initial_approval_date": "2021-01-14", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202570s030lbl.pdf", "description": "The U.S. Food and Drug Administration granted approval to crizotinib for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.", @@ -547,7 +547,7 @@ { "id": 49, "document_id": 25, - "indication": "TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test", + "indication": "TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.", "initial_approval_date": "2013-05-29", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s000lbl.pdf", "description": "The U.S. Food and Drug Administration granted approval to dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test.", @@ -624,7 +624,7 @@ { "id": 56, "document_id": 26, - "indication": "VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test", + "indication": "VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.", "initial_approval_date": "2018-09-27", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211288s000lbl.pdf", "description": "The U.S. Food and Drug Administration granted approval to dacomitinib for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by an FDA-approved test.", @@ -1089,7 +1089,7 @@ "indication": "YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>=1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab.", "initial_approval_date": "2020-05-15", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s109lbl.pdf", - "description": "The U.S. Food and Drug Administration granted approval to ipilimumab in combination with nivolumab for the first-line treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>=1%), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations", + "description": "The U.S. Food and Drug Administration granted approval to ipilimumab in combination with nivolumab for the first-line treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>=1%), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.", "raw_biomarkers": "PD-L1 >= 1% and no EGFR or ALK genomic tumor aberrations", "raw_cancer_type": "metastatic non-small cell lung cancer", "raw_therapeutics": "Yervoy (ipilimumab) in combination with nivolumab" @@ -1108,7 +1108,7 @@ { "id": 100, "document_id": 46, - "indication": "TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy", + "indication": "TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.", "initial_approval_date": "2022-05-25", "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211192s009lbl.pdf", "description": "The U.S. Food and Drug Administration granted approval to ivosidenib as a monotherapy or in combination with azacitidine for the treatment of adult patients newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.", diff --git a/utils/test.py b/utils/test.py index 55af0a6..c00c160 100644 --- a/utils/test.py +++ b/utils/test.py @@ -1,7 +1,6 @@ import unittest -import json_utils -import test_utils +import json_utils # Local import class Base(unittest.TestCase): @classmethod @@ -10,7 +9,6 @@ def setUpClass(cls): Import json files from referenced/ and make them available to inherited test classes """ cls.input_paths = { - 'about': 'referenced/about.json', 'agents': 'referenced/agents.json', 'biomarkers': 'referenced/biomarkers.json', 'contributions': 'referenced/contributions.json', @@ -31,6 +29,10 @@ def setUpClass(cls): class TestDataIntegrity(Base): + """ + Assess that there are no errors with data entry + """ + def test_document_url_matches_citation(self): """ Assess if `url` field matches the url contained in the `citation` for documents where the url should be @@ -55,9 +57,7 @@ def test_document_url_matches_citation(self): def test_no_mismatch_between_document_for_indication_and_statement(self): """ Assess if document associated with indications and associated statements differ - While statement['reportedIn'] is of type list, """ - with self.subTest(): for statement in self.data['statements']: statement_documents = statement['reportedIn'] @@ -82,14 +82,42 @@ def test_no_mismatch_between_document_for_indication_and_statement(self): ) def test_missing_id_values(self): - # Logic to check for missing ID values - pass + """ + Assess if any id values are missing from any referenced records + """ + for record_type, records in self.data.items(): + with self.subTest(record_type=record_type): + idx_values = [record['id'] for record in records] + idx_range = list(range(0, len(records))) + if not idx_values == idx_range: + missing_ids = [idx for idx in idx_range if idx not in idx_values] + missing_ids_str = ", ".join(str(idx) for idx in missing_ids) + self.fail( + f"Missing id values detected.\n" + + f" - Affected ID(s): {missing_ids_str}\n" + f" - Total affected: {len(missing_ids)}" + ) class TestDateConsistency(Base): - def test_accessed_date_vs_publication_date(self): - # Logic to ensure accessed date is equal to or more recent than publication date - pass + """ + Assess that various keys containing values for dates align as they should + """ + def test_document_accessed_date_vs_publication_date(self): + """ + Assess that the accessed date is more recent than the publication date for each document + """ + with self.subTest(): + failed_records = [document for document in self.data['documents'] if not (document['access_date'] >= document['publication_date'])] + if failed_records: + failed_record_ids = ", ".join(str(record['id']) for record in failed_records) + self.fail( + f"Access date before publication date detected.\n" + f" - File: documents\n" + f" - Affected ID(s): {failed_record_ids}\n" + f" - Total affected: {len(failed_records)}" + ) def test_last_updated_vs_first_published(self): # Logic to check if last_updated dates come before first published dates @@ -106,8 +134,31 @@ def test_publication_date_consistency(self): class TestFormatting(Base): def test_ending_periods(self): - # Logic to ensure all indications and descriptions end with periods - pass + """ + Ensure that all indications and descriptions end with periods + """ + # tuples of file (records; list[dict]) and key for each record in records + tests = [ + ('indications', 'description'), + ('indications', 'indication') + ] + + for record_type, key in tests: + with self.subTest(record_type=record_type, key=key): + failed_records = [] + for record in self.data[record_type]: + if record[key][-1] != '.': + failed_records.append(record['id']) + + if failed_records: + failed_record_ids = ", ".join(str(record_id) for record_id in failed_records) + self.fail( + f"Descriptions and indications that do not end with a period detected.\n" + f" - File: {record_type}\n" + f" - Key: {key}\n" + f" - Affected ID(s): {failed_record_ids}\n" + f" - Total affected: {len(failed_records)}" + ) def test_spelling_errors(self): # Logic to print all strings and value counts to look for misspellings @@ -115,10 +166,8 @@ def test_spelling_errors(self): def test_trailing_spaces(self): """ - Assess if any values have trailing spaces in any of the json key pairs + Assess if any strings values have trailing spaces in any of the json key pairs """ - - # Logic to check for trailing spaces in indications or descriptions tests = [ # tuples of file (records; list[dict]) and key for each record in records # the key should be present in each record @@ -138,10 +187,10 @@ def test_trailing_spaces(self): ('documents', 'url'), ('documents', 'url_drug'), ('genes', 'label'), + ('indications', 'description'), ('indications', 'indication'), ('indications', 'initial_approval_date'), ('indications', 'initial_approval_url'), - ('indications', 'description'), ('indications', 'raw_biomarkers'), ('indications', 'raw_cancer_type'), ('indications', 'raw_therapeutics'), @@ -159,7 +208,11 @@ def test_trailing_spaces(self): for record_type, key in tests: with self.subTest(record_type=record_type, key=key): - failed_records = test_utils.Test.find_trailing_spaces(records=self.data[record_type], key=key) + failed_records = [] + for record in self.data[record_type]: + if record[key] != record[key].rstrip(): + failed_records.append(record['id']) + if failed_records: failed_record_ids = ", ".join(str(failed_record) for failed_record in failed_records) self.fail(