2024 November 7th release (#34)

vanallenlab · Nov 7, 2024 · bb3dff5 · bb3dff5
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diff --git a/docs/content-changelog.md b/docs/content-changelog.md
@@ -1,6 +1,15 @@
 # Content Changelog
 The following changes have been made to the content catalogued within the Molecular Oncology Almanac knowledge base.
 
+## November 2024 release
+Added entries:
+- (FDA) [_BCR_::_ABL1_ and sensitivity to asciminib](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-asciminib-newly-diagnosed-chronic-myeloid-leukemia) for patients with chronic myeloid leukemia in chronic phase.
+- (FDA) _BCR_::_ABL1_ and _ABL1_ p.T315I and sensitivity to asciminib for patients with chronic myeloid leukemia in chronic phase.
+- (FDA) [_PIK3CA_ variants and sensitivity to inavolisib for patients with HR+, HER2-negative, locally advanced or metastatic breast cancer](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-inavolisib-palbociclib-and-fulvestrant-endocrine-resistant-pik3ca-mutated-hr-positive).
+
+Revised entries:
+- (FDA) _BCR_::_ABL1_ and sensitivity to asciminib for patients with previously treated chronic myeloid leukemia in chronic phase was generalized to be for previously treatmented patients, instead of specifically for previously treated with two or more TKIs.
+
 ## October 2024 release
 Added entries:
 - (FDA) [_EGFR_ p.L858R and exon 19 deletions and sensitivty to amivantamab-vmjw in combination with carboplatin and pemetrexed for the treatment of patients with non-small cell lung cancer](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-carboplatin-and-pemetrexed-non-small-cell-lung-cancer-egfr-exon-19).

diff --git a/molecular-oncology-almanac.json b/molecular-oncology-almanac.json
@@ -212,15 +212,15 @@
         "therapy_resistance": "",
         "favorable_prognosis": "",
         "predictive_implication": "FDA-Approved",
-        "description": "The U.S. Food and Drug Administraton (FDA) granted accelerated approval based on major molecular resposne to Scemblix (asciminib) for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs).",
+        "description": "The U.S. Food and Drug Administraton (FDA) granted approval to asciminib for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) that have been previously treated.",
         "source_type": "FDA",
-        "citation": "Novartis Pharmaceuticals Corporation. Scemblix (asciminib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000Orig1lbl.pdf. Revised October 2021. Accessed November 3, 2021.",
-        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000Orig1lbl.pdf",
+        "citation": "Novartis Pharmaceuticals Corporation. Scemblix (asciminib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf. Revised October 2024. Accessed November 6, 2024.",
+        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf",
         "doi": "",
         "pmid": "",
         "nct": "",
-        "publication_date": "2021-10-01",
-        "last_updated": "2021-11-03",
+        "publication_date": "2024-10-29",
+        "last_updated": "2024-11-06",
         "_deprecated": false
     },
     {
@@ -33175,5 +33175,131 @@
         "publication_date": "2024-09-25",
         "last_updated": "2024-10-02",
         "_deprecated": false
+    },
+    {
+        "feature_type": "Rearrangement",
+        "gene1": "BCR",
+        "gene2": "ABL1",
+        "rearrangement_type": "Fusion",
+        "locus": "",
+        "disease": "Chronic Myeloid Leukemia",
+        "context": "",
+        "oncotree_term": "Chronic Myelogenous Leukemia",
+        "oncotree_code": "CML",
+        "therapy_name": "Asciminib",
+        "therapy_strategy": "BCR-ABL 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 asciminib for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).",
+        "source_type": "FDA",
+        "citation": "Novartis Pharmaceuticals Corporation. Scemblix (asciminib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf. Revised October 2024. Accessed November 6, 2024.",
+        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf",
+        "doi": "",
+        "pmid": "",
+        "nct": "",
+        "publication_date": "2024-10-29",
+        "last_updated": "2024-11-06",
+        "_deprecated": false
+    },
+    {
+        "feature_type": "Rearrangement",
+        "gene1": "BCR",
+        "gene2": "ABL1",
+        "rearrangement_type": "Fusion",
+        "locus": "",
+        "disease": "Chronic Myeloid Leukemia",
+        "context": "",
+        "oncotree_term": "Chronic Myelogenous Leukemia",
+        "oncotree_code": "CML",
+        "therapy_name": "Asciminib",
+        "therapy_strategy": "BCR-ABL 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 asciminib for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and ABL1 p.T315I.",
+        "source_type": "FDA",
+        "citation": "Novartis Pharmaceuticals Corporation. Scemblix (asciminib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf. Revised October 2024. Accessed November 6, 2024.",
+        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf",
+        "doi": "",
+        "pmid": "",
+        "nct": "",
+        "publication_date": "2024-10-29",
+        "last_updated": "2024-11-06",
+        "_deprecated": false
+    },
+    {
+        "feature_type": "Somatic Variant",
+        "gene": "ABL1",
+        "chromosome": "9",
+        "start_position": 133748283,
+        "end_position": 133748283,
+        "reference_allele": "C",
+        "alternate_allele": "T",
+        "cdna_change": "c.944C>T",
+        "protein_change": "p.T315I",
+        "variant_annotation": "Missense",
+        "exon": 5,
+        "rsid": "rs121913459",
+        "disease": "Chronic Myeloid Leukemia",
+        "context": "",
+        "oncotree_term": "Chronic Myelogenous Leukemia",
+        "oncotree_code": "CML",
+        "therapy_name": "Asciminib",
+        "therapy_strategy": "BCR-ABL 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 asciminib for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and ABL1 p.T315I.",
+        "source_type": "FDA",
+        "citation": "Novartis Pharmaceuticals Corporation. Scemblix (asciminib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf. Revised October 2024. Accessed November 6, 2024.",
+        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf",
+        "doi": "",
+        "pmid": "",
+        "nct": "",
+        "publication_date": "2024-10-29",
+        "last_updated": "2024-11-06",
+        "_deprecated": false
+    },
+    {
+        "feature_type": "Somatic Variant",
+        "gene": "PIK3CA",
+        "chromosome": "",
+        "start_position": "",
+        "end_position": "",
+        "reference_allele": "",
+        "alternate_allele": "",
+        "cdna_change": "",
+        "protein_change": "",
+        "variant_annotation": "",
+        "exon": "",
+        "rsid": "",
+        "disease": "Breast Cancer",
+        "context": "",
+        "oncotree_term": "Invasive Breast Carcinoma",
+        "oncotree_code": "BRCA",
+        "therapy_name": "Inavolisib + Fulvestrant + Palbociclib",
+        "therapy_strategy": "PI3K/AKT/mTOR inhibition + ER signaling inhibition + CDK4/6 inhibition",
+        "therapy_type": "Combination therapy",
+        "therapy_sensitivity": 1,
+        "therapy_resistance": "",
+        "favorable_prognosis": "",
+        "predictive_implication": "FDA-Approved",
+        "description": "The U.S. Food and Drug Administration (FDA) granted approval to inavolisib in combination with fulvestrant and palbociclib 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. Inavolisib's drug label further states that patients should be selected based on the presence of one or more PIK3CA mutations in plasma specimen. This approval is based on INAVO120 (NCT04191499), a phase 3 double-blind, randomized trial, where PIK3CA mutation status was prospectively determined in a central laboratory using the FoundationOne Liquid CDx assay on plasma-derived circulating tumor DNA (ctDNA) or in local laboratories using various validated polymerase chain reaction (PCR) or next-generation sequencing (NGS) assays on tumor tissue or plasma.",
+        "source_type": "FDA",
+        "citation": "Genentech, Inc. Itovebi (inavolisib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219249s000lbl.pdf. Revised October 2024. Accessed November 6, 2024.",
+        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219249s000lbl.pdf",
+        "doi": "",
+        "pmid": "",
+        "nct": "",
+        "publication_date": "2024-10-10",
+        "last_updated": "2024-11-07",
+        "_deprecated": false
     }
 ]