diff --git a/docs/content-changelog.md b/docs/content-changelog.md index 24c097e..61060ed 100644 --- a/docs/content-changelog.md +++ b/docs/content-changelog.md @@ -1,6 +1,19 @@ # Content Changelog The following changes have been made to the content catalogued within the Molecular Oncology Almanac knowledge base. +## June 2024 release +Added entries: +- (FDA) _ALK_ fusions and sensitivity to alectinib for patients with non-small cell lung cancer. +- (FDA) _BRAF_ p.V600E/K (p.V600 variants), rearrangements, and fusions and sensitivity to tovorafenib for patients with low-grade glioma. +- (FDA) _EGFR_ p.L858R and exon 19 deletions and sensitivity to erlotinib for patients with non-small cell lung cancer. +- (FDA) _EGFR_ p.L858R and exon 19 deletions and sensitivity to gefitinib for patients with non-small cell lung cancer. + +Revised entries: +- (FDA) _RET_ fusions and sensitivity to selpercatinib for patients with solid tumors is now indicated for pediatric patients aged 2 and older, in addition to adult patients. +- (FDA) _RET_ fusions and sensitivity to selpercatinib for patients with thyroid cancer is now indicated for pediatric patients aged 2 and older, revised from age 12 or older. +- (FDA) _RET_ variants and sensitivity to selpercatinib for patients with medullary thyroid cancer is now indicated for pediatric patients aged 2 and older, revised from age 12 or older. +- (FDA) _RET_ fusion and sensitivity to selpercatinib for patients with non-small cell lung cancer's description and publication date were revised. + ## April 2024 release Added entries: - (FDA) ABL1 p.T315I and sensitivity to ponatinib for patients with acute lymphoid leukemia. diff --git a/molecular-oncology-almanac.json b/molecular-oncology-almanac.json index 46f15e3..ba70969 100644 --- a/molecular-oncology-almanac.json +++ b/molecular-oncology-almanac.json @@ -1472,15 +1472,15 @@ "therapy_resistance": "", "favorable_prognosis": "", "predictive_implication": "FDA-Approved", - "description": "The U.S. Food and Drug Administration (FDA) granted approval for selpercatinib for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to selpercatinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, as detected by an FDA-approved test.", "source_type": "FDA", "citation": "Eli Lily and Company. Retevmo (selpercatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213246s000lbl.pdf. Revised May 2020. Accessed October 22, 2020.", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213246s000lbl.pdf", "doi": "", "pmid": "", "nct": "", - "publication_date": "2020-05-01", - "last_updated": "2020-10-22", + "publication_date": "2020-05-08", + "last_updated": "2024-06-03", "_deprecated": false }, { @@ -1500,15 +1500,15 @@ "therapy_resistance": "", "favorable_prognosis": "", "predictive_implication": "FDA-Approved", - "description": "The U.S. Food and Drug Administration (FDA) granted approval for selpercatinib for 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-refactory (if radioactive iodine is appropriate).", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to selpercatinib 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-refactory (if radioactive iodine is appropriate).", "source_type": "FDA", - "citation": "Eli Lily and Company. Retevmo (selpercatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213246s000lbl.pdf. Revised May 2020. Accessed October 22, 2020.", - "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213246s000lbl.pdf", + "citation": "Eli Lily and Company. Retevmo (selpercatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.pdf. Revised May 2024. Accessed June 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.pdf", "doi": "", "pmid": "", "nct": "", - "publication_date": "2020-05-01", - "last_updated": "2020-10-22", + "publication_date": "2024-05-29", + "last_updated": "2024-06-03", "_deprecated": false }, { @@ -17768,15 +17768,15 @@ "therapy_resistance": "", "favorable_prognosis": "", "predictive_implication": "FDA-Approved", - "description": "The U.S. Food and Drug Administration (FDA) granted approval for selpercatinib for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.", + "description": "The U.S. Food and Drug Administration (FDA) 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.", "source_type": "FDA", - "citation": "Eli Lily and Company. Retevmo (selpercatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213246s000lbl.pdf. Revised May 2020. Accessed October 22, 2020.", - "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213246s000lbl.pdf", + "citation": "Eli Lily and Company. Retevmo (selpercatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.pdf. Revised May 2024. Accessed June 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.pdf", "doi": "", "pmid": "", "nct": "", - "publication_date": "2020-05-01", - "last_updated": "2020-10-22", + "publication_date": "2024-05-29", + "last_updated": "2024-06-03", "_deprecated": false }, { @@ -28452,15 +28452,15 @@ "therapy_resistance": "", "favorable_prognosis": "", "predictive_implication": "FDA-Approved", - "description": "The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Retevmo (selpercatinib) for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alterantive treatment options.", + "description": "The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Retevmo (selpercatinib) for the treatment of adult and pediatric patients 2 years of age and older with 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 alterantive treatment options. This indication was approved for adult patients on 2022-09-21 and pediatric patients on 2024-05-29.", "source_type": "FDA", - "citation": "Eli Lily and Company. Retevmo (selpercatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213246s008lbl.pdf. Revised September 2022. Accessed December 1, 2022.", - "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213246s008lbl.pdf", + "citation": "Eli Lily and Company. Retevmo (selpercatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.pdf. Revised May 2024. Accessed June 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.pdf", "doi": "", "pmid": "", "nct": "", - "publication_date": "2022-09-01", - "last_updated": "2022-12-01", + "publication_date": "2024-05-29", + "last_updated": "2024-06-03", "_deprecated": false }, { @@ -31992,5 +31992,264 @@ "publication_date": "2013-12-20", "last_updated": "2024-04-11", "_deprecated": false + }, + { + "feature_type": "Rearrangement", + "gene1": "ALK", + "gene2": "", + "rearrangement_type": "Fusion", + "locus": "", + "disease": "Non-Small Cell Lung Cancer", + "context": "Metastatic", + "oncotree_term": "Non-Small Cell Lung Cancer", + "oncotree_code": "NSCLC", + "therapy_name": "Alectinib", + "therapy_strategy": "ALK inhibition", + "therapy_type": "Targeted therapy", + "therapy_sensitivity": 1, + "therapy_resistance": "", + "favorable_prognosis": "", + "predictive_implication": "FDA-Approved", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to alectinib for the adjuvant treatment of adult patients following tumor resection of 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.", + "source_type": "FDA", + "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 April 2024. Accessed June 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208434s015lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-04-18", + "last_updated": "2024-06-03", + "_deprecated": false + }, + { + "feature_type": "Somatic Variant", + "gene": "BRAF", + "chromosome": "7", + "start_position": 140453136, + "end_position": 140453137, + "reference_allele": "AC", + "alternate_allele": "TT", + "cdna_change": "c.1798_1799GT>AA", + "protein_change": "p.V600K", + "variant_annotation": "Missense", + "exon": 15, + "rsid": "rs121913227", + "disease": "Low-grade glioma", + "context": "", + "oncotree_term": "Low-Grade Glioma, NOS", + "oncotree_code": "LGGNOS", + "therapy_name": "Tovorafenib", + "therapy_strategy": "RAF inhibition", + "therapy_type": "Targeted therapy", + "therapy_sensitivity": 1, + "therapy_resistance": "", + "favorable_prognosis": "", + "predictive_implication": "FDA-Approved", + "description": "The U.S. Food and Drug Administration (FDA) 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.", + "source_type": "FDA", + "citation": "Day One Biopharmaceuticals, Inc. Ojemda (tovorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf. Revised April 2024. Accessed June 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-04-23", + "last_updated": "2024-06-03", + "_deprecated": false + }, + { + "feature_type": "Rearrangement", + "gene1": "BRAF", + "gene2": "", + "rearrangement_type": "", + "locus": "", + "disease": "Low-grade glioma", + "context": "", + "oncotree_term": "Low-Grade Glioma, NOS", + "oncotree_code": "LGGNOS", + "therapy_name": "Tovorafenib", + "therapy_strategy": "RAF inhibition", + "therapy_type": "Targeted therapy", + "therapy_sensitivity": 1, + "therapy_resistance": "", + "favorable_prognosis": "", + "predictive_implication": "FDA-Approved", + "description": "The U.S. Food and Drug Administration (FDA) 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.", + "source_type": "FDA", + "citation": "Day One Biopharmaceuticals, Inc. Ojemda (tovorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf. Revised April 2024. Accessed June 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-04-23", + "last_updated": "2024-06-03", + "_deprecated": false + }, + { + "feature_type": "Rearrangement", + "gene1": "BRAF", + "gene2": "", + "rearrangement_type": "Fusion", + "locus": "", + "disease": "Low-grade glioma", + "context": "", + "oncotree_term": "Low-Grade Glioma, NOS", + "oncotree_code": "LGGNOS", + "therapy_name": "Tovorafenib", + "therapy_strategy": "RAF inhibition", + "therapy_type": "Targeted therapy", + "therapy_sensitivity": 1, + "therapy_resistance": "", + "favorable_prognosis": "", + "predictive_implication": "FDA-Approved", + "description": "The U.S. Food and Drug Administration (FDA) 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.", + "source_type": "FDA", + "citation": "Day One Biopharmaceuticals, Inc. Ojemda (tovorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf. Revised April 2024. Accessed June 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-04-23", + "last_updated": "2024-06-03", + "_deprecated": false + }, + { + "feature_type": "Somatic Variant", + "gene": "EGFR", + "chromosome": "7", + "start_position": "", + "end_position": "", + "reference_allele": "", + "alternate_allele": "", + "cdna_change": "", + "protein_change": "", + "variant_annotation": "Deletion", + "exon": 19, + "rsid": "", + "disease": "Non-Small Cell Lung Cancer", + "context": "Metastatic", + "oncotree_term": "Non-Small Cell Lung Cancer", + "oncotree_code": "NSCLC", + "therapy_name": "Erlotinib", + "therapy_strategy": "EGFR inhibition", + "therapy_type": "Targeted therapy", + "therapy_sensitivity": 1, + "therapy_resistance": "", + "favorable_prognosis": "", + "predictive_implication": "FDA-Approved", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to erlotinib for the treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (p.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.", + "source_type": "FDA", + "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 June 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2016-10-18", + "last_updated": "2024-06-03", + "_deprecated": false + }, + { + "feature_type": "Somatic Variant", + "gene": "EGFR", + "chromosome": "7", + "start_position": 55259515, + "end_position": 55259515, + "reference_allele": "T", + "alternate_allele": "G", + "cdna_change": "c.2573T>G", + "protein_change": "p.L858R", + "variant_annotation": "Missense", + "exon": 21, + "rsid": "rs121434568", + "disease": "Non-Small Cell Lung Cancer", + "context": "Metastatic", + "oncotree_term": "Non-Small Cell Lung Cancer", + "oncotree_code": "NSCLC", + "therapy_name": "Erlotinib", + "therapy_strategy": "EGFR inhibition", + "therapy_type": "Targeted therapy", + "therapy_sensitivity": 1, + "therapy_resistance": "", + "favorable_prognosis": "", + "predictive_implication": "FDA-Approved", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to erlotinib for the treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (p.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.", + "source_type": "FDA", + "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 June 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2016-10-18", + "last_updated": "2024-06-03", + "_deprecated": false + }, + { + "feature_type": "Somatic Variant", + "gene": "EGFR", + "chromosome": "7", + "start_position": "", + "end_position": "", + "reference_allele": "", + "alternate_allele": "", + "cdna_change": "", + "protein_change": "", + "variant_annotation": "Deletion", + "exon": 19, + "rsid": "", + "disease": "Non-Small Cell Lung Cancer", + "context": "Metastatic", + "oncotree_term": "Non-Small Cell Lung Cancer", + "oncotree_code": "NSCLC", + "therapy_name": "Gefitinib", + "therapy_strategy": "EGFR inhibition", + "therapy_type": "Targeted therapy", + "therapy_sensitivity": 1, + "therapy_resistance": "", + "favorable_prognosis": "", + "predictive_implication": "FDA-Approved", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to gefitinib for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.", + "source_type": "FDA", + "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 June 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206995s004lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2021-05-05", + "last_updated": "2024-06-03", + "_deprecated": false + }, + { + "feature_type": "Somatic Variant", + "gene": "EGFR", + "chromosome": "7", + "start_position": 55259515, + "end_position": 55259515, + "reference_allele": "T", + "alternate_allele": "G", + "cdna_change": "c.2573T>G", + "protein_change": "p.L858R", + "variant_annotation": "Missense", + "exon": 21, + "rsid": "rs121434568", + "disease": "Non-Small Cell Lung Cancer", + "context": "Metastatic", + "oncotree_term": "Non-Small Cell Lung Cancer", + "oncotree_code": "NSCLC", + "therapy_name": "Gefitinib", + "therapy_strategy": "EGFR inhibition", + "therapy_type": "Targeted therapy", + "therapy_sensitivity": 1, + "therapy_resistance": "", + "favorable_prognosis": "", + "predictive_implication": "FDA-Approved", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to gefitinib for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.", + "source_type": "FDA", + "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 June 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206995s004lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2021-05-05", + "last_updated": "2024-06-03", + "_deprecated": false } ] \ No newline at end of file