From 73053f98a7b827e65db817499b13d73d4152b2c0 Mon Sep 17 00:00:00 2001 From: Brendan Reardon Date: Fri, 25 Oct 2024 21:39:54 +0200 Subject: [PATCH] Update db to 2024-10-03 (#24) --- .../moalmanac/molecular-oncology-almanac.json | 1300 ++++++++++++++++- ...ll-request.md => pull_request_template.md} | 0 moalmanac/config.ini | 2 +- 3 files changed, 1260 insertions(+), 42 deletions(-) rename docs/{template-pull-request.md => pull_request_template.md} (100%) diff --git a/datasources/moalmanac/molecular-oncology-almanac.json b/datasources/moalmanac/molecular-oncology-almanac.json index d92285e..cbfc62e 100644 --- a/datasources/moalmanac/molecular-oncology-almanac.json +++ b/datasources/moalmanac/molecular-oncology-almanac.json @@ -1,5 +1,5 @@ { - "release": "2024-04-11", + "release": "2024-10-03", "version": "1.3.0", "genes": [ "ABL1", @@ -1680,15 +1680,15 @@ "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, "feature_display": "RET Fusion" }, @@ -1709,15 +1709,15 @@ "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/2024/213246s009lbl.pdf. Revised June 2024. Accessed July 11, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s009lbl.pdf", "doi": "", "pmid": "", "nct": "", - "publication_date": "2020-05-01", - "last_updated": "2020-10-22", + "publication_date": "2024-06-12", + "last_updated": "2024-07-11", "_deprecated": false, "feature_display": "RET Fusion" }, @@ -8399,7 +8399,7 @@ "therapy_resistance": "", "favorable_prognosis": "", "predictive_implication": "FDA-Approved", - "description": "Osimertinib is a kinase inhibitor indicated for the treatment of 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.", + "description": "The U.S. Food and Drug Administration (FDA) granted approval to osimertinib, a kinase inhibitor, 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.", "source_type": "FDA", "citation": "AstraZeneca Pharmaceuticals, LP. Tagrisso (osimertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s006lbl.pdf. Revised March 2017. Accessed March 4, 2024.", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s006lbl.pdf", @@ -8407,7 +8407,7 @@ "pmid": "", "nct": "", "publication_date": "2017-03-30", - "last_updated": "2024-03-04", + "last_updated": "2024-10-02", "_deprecated": false, "feature_display": "EGFR p.T790M (Missense)" }, @@ -11123,7 +11123,7 @@ "protein_change": "p.R172K", "variant_annotation": "Missense", "exon": 4, - "rsid": "", + "rsid": "rs121913503", "disease": "Acute Myeloid Leukemia", "context": "Relapsed or refractory", "oncotree_term": "Acute Myeloid Leukemia", @@ -11303,7 +11303,7 @@ "protein_change": "p.R172K", "variant_annotation": "Missense", "exon": 4, - "rsid": "", + "rsid": "rs121913503", "disease": "Myelodysplastic Syndromes", "context": "", "oncotree_term": "Myelodysplasia", @@ -18443,15 +18443,15 @@ "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/2024/213246s011s013lbl.pdf. Revised September 2024. Accessed October 2, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s011s013lbl.pdf", "doi": "", "pmid": "", "nct": "", - "publication_date": "2020-05-01", - "last_updated": "2020-10-22", + "publication_date": "2024-09-27", + "last_updated": "2024-10-02", "_deprecated": false, "feature_display": "RET" }, @@ -24808,13 +24808,13 @@ "therapy_sensitivity": "", "therapy_resistance": "", "favorable_prognosis": 0, - "predictive_implication": "Clinical evidence", + "predictive_implication": "Clinical trial", "description": "CCND1 amplification showed reduced recurrence-free survival in a randomized control trial of postmenopausal breast cancer patients.", "source_type": "Journal", "citation": "Bostner, Josefine, et al. Amplification of CCND1 and PAK1 as predictors of recurrence and tamoxifen resistance in postmenopausal breast cancer. Oncogene 26.49 (2007): 6997-7005.", "url": "https://doi.org/10.1038/sj.onc.1210506", "doi": "10.1038/sj.onc.1210506", - "pmid": 7486065, + "pmid": 17486065, "nct": "", "publication_date": "2007-05-07", "last_updated": "2017-11-03", @@ -26488,13 +26488,13 @@ "therapy_sensitivity": "", "therapy_resistance": "", "favorable_prognosis": 0, - "predictive_implication": "Clinical evidence", + "predictive_implication": "Clinical trial", "description": "PAK1 amplification showed reduced recurrence-free survival and decreased benefit from Tamoxifen in a randomized control trial of postmenopausal breast cancer patients.", "source_type": "Journal", "citation": "Bostner, Josefine, et al. Amplification of CCND1 and PAK1 as predictors of recurrence and tamoxifen resistance in postmenopausal breast cancer. Oncogene 26.49 (2007): 6997-7005.", "url": "https://doi.org/10.1038/sj.onc.1210506", "doi": "10.1038/sj.onc.1210506", - "pmid": 7486065, + "pmid": 17486065, "nct": "", "publication_date": "2007-05-07", "last_updated": "2019-01-29", @@ -26516,13 +26516,13 @@ "therapy_sensitivity": 0, "therapy_resistance": "", "favorable_prognosis": "", - "predictive_implication": "Clinical evidence", + "predictive_implication": "Clinical trial", "description": "PAK1 amplification showed reduced recurrence-free survival and decreased benefit from Tamoxifen in a randomized control trial of postmenopausal breast cancer patients.", "source_type": "Journal", "citation": "Bostner, Josefine, et al. Amplification of CCND1 and PAK1 as predictors of recurrence and tamoxifen resistance in postmenopausal breast cancer. Oncogene 26.49 (2007): 6997-7005.", "url": "https://doi.org/10.1038/sj.onc.1210506", "doi": "10.1038/sj.onc.1210506", - "pmid": 7486065, + "pmid": 17486065, "nct": "", "publication_date": "2007-05-07", "last_updated": "2019-01-29", @@ -29462,15 +29462,15 @@ "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, "feature_display": "RET Fusion" }, @@ -32278,7 +32278,7 @@ "oncotree_code": "BRCA", "therapy_name": "Capivasertib + Fulvestrant", "therapy_strategy": "PI3K/AKT/mTOR inhibition + ER signaling inhibition", - "therapy_type": "Targeted therapy", + "therapy_type": "Combination therapy", "therapy_sensitivity": 1, "therapy_resistance": "", "favorable_prognosis": "", @@ -32314,7 +32314,7 @@ "oncotree_code": "BRCA", "therapy_name": "Capivasertib + Fulvestrant", "therapy_strategy": "PI3K/AKT/mTOR inhibition + ER signaling inhibition", - "therapy_type": "Targeted therapy", + "therapy_type": "Combination therapy", "therapy_sensitivity": 1, "therapy_resistance": "", "favorable_prognosis": "", @@ -32350,7 +32350,7 @@ "oncotree_code": "BRCA", "therapy_name": "Capivasertib + Fulvestrant", "therapy_strategy": "PI3K/AKT/mTOR inhibition + ER signaling inhibition", - "therapy_type": "Targeted therapy", + "therapy_type": "Combination therapy", "therapy_sensitivity": 1, "therapy_resistance": "", "favorable_prognosis": "", @@ -32386,7 +32386,7 @@ "oncotree_code": "BRCA", "therapy_name": "Capivasertib + Fulvestrant", "therapy_strategy": "PI3K/AKT/mTOR inhibition + ER signaling inhibition", - "therapy_type": "Targeted therapy", + "therapy_type": "Combination therapy", "therapy_sensitivity": 1, "therapy_resistance": "", "favorable_prognosis": "", @@ -32422,7 +32422,7 @@ "oncotree_code": "BRCA", "therapy_name": "Capivasertib + Fulvestrant", "therapy_strategy": "PI3K/AKT/mTOR inhibition + ER signaling inhibition", - "therapy_type": "Targeted therapy", + "therapy_type": "Combination therapy", "therapy_sensitivity": 1, "therapy_resistance": "", "favorable_prognosis": "", @@ -32450,7 +32450,7 @@ "oncotree_code": "BRCA", "therapy_name": "Capivasertib + Fulvestrant", "therapy_strategy": "PI3K/AKT/mTOR inhibition + ER signaling inhibition", - "therapy_type": "Targeted therapy", + "therapy_type": "Combination therapy", "therapy_sensitivity": 1, "therapy_resistance": "", "favorable_prognosis": "", @@ -32478,7 +32478,7 @@ "oncotree_code": "BRCA", "therapy_name": "Neratinib + Capecitabine", "therapy_strategy": "ER signaling inhibition + Thymidylate synthase inhibitor", - "therapy_type": "Targeted therapy + Chemotherapy", + "therapy_type": "Combination therapy", "therapy_sensitivity": 1, "therapy_resistance": "", "favorable_prognosis": "", @@ -32586,7 +32586,7 @@ "oncotree_code": "NSCLC", "therapy_name": "Amivantamab-vmjw + Carboplatin + Pemetrexed", "therapy_strategy": "EGFR inhibition + Platinum-based chemotherapy + Antifolate", - "therapy_type": "Targeted therapy + Chemotherapy + Chemotherapy", + "therapy_type": "Combination therapy", "therapy_sensitivity": 1, "therapy_resistance": "", "favorable_prognosis": "", @@ -32622,7 +32622,7 @@ "oncotree_code": "NSCLC", "therapy_name": "Cisplatin + Osimertinib + Pemetrexed", "therapy_strategy": "Platinum-based chemotherapy + EGFR inhibition + Antifolate", - "therapy_type": "Chemotherapy + Targeted therapy + Chemotherapy", + "therapy_type": "Combination therapy", "therapy_sensitivity": 1, "therapy_resistance": "", "favorable_prognosis": "", @@ -32658,7 +32658,7 @@ "oncotree_code": "NSCLC", "therapy_name": "Cisplatin + Osimertinib + Pemetrexed", "therapy_strategy": "Platinum-based chemotherapy + EGFR inhibition + Antifolate", - "therapy_type": "Chemotherapy + Targeted therapy + Chemotherapy", + "therapy_type": "Combination therapy", "therapy_sensitivity": 1, "therapy_resistance": "", "favorable_prognosis": "", @@ -32699,7 +32699,7 @@ "therapy_resistance": "", "favorable_prognosis": "", "predictive_implication": "FDA-Approved", - "description": "The U.S. Food and Drug Administration (FDA) granted approval for osimertinib for for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or an exon 21 p.L858R variant, as detected by an FDA-approved test.", + "description": "The U.S. Food and Drug Administration (FDA) granted approval for osimertinib for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or an exon 21 p.L858R variant, as detected by an FDA-approved test.", "source_type": "FDA", "citation": "AstraZeneca Pharmaceuticals, LP. Tagrisso (osimertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s008lbl.pdf. Revised April 2018. Accessed March 4, 2024.", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s008lbl.pdf", @@ -32735,7 +32735,7 @@ "therapy_resistance": "", "favorable_prognosis": "", "predictive_implication": "FDA-Approved", - "description": "The U.S. Food and Drug Administration (FDA) granted approval for osimertinib for for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or an exon 21 p.L858R variant, as detected by an FDA-approved test.", + "description": "The U.S. Food and Drug Administration (FDA) granted approval for osimertinib for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or an exon 21 p.L858R variant, as detected by an FDA-approved test.", "source_type": "FDA", "citation": "AstraZeneca Pharmaceuticals, LP. Tagrisso (osimertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s008lbl.pdf. Revised April 2018. Accessed March 4, 2024.", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s008lbl.pdf", @@ -33106,6 +33106,1224 @@ "last_updated": "2024-04-11", "_deprecated": false, "feature_display": "ABL1 p.T315I (Missense)" + }, + { + "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_display": "ALK Fusion" + }, + { + "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_display": "BRAF p.V600K (Missense)" + }, + { + "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_display": "BRAF" + }, + { + "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_display": "BRAF Fusion" + }, + { + "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_display": "EGFR Exon 19 (Deletion)" + }, + { + "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_display": "EGFR p.L858R (Missense)" + }, + { + "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_display": "EGFR Exon 19 (Deletion)" + }, + { + "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, + "feature_display": "EGFR p.L858R (Missense)" + }, + { + "feature_type": "Rearrangement", + "gene1": "NTRK1", + "gene2": "", + "rearrangement_type": "Fusion", + "locus": "", + "disease": "Any solid tumor", + "context": "", + "oncotree_term": "Any solid tumor", + "oncotree_code": "", + "therapy_name": "Repotrectinib", + "therapy_strategy": "TRK 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 repotrectinib for the treatment of adult and pediatric patients of age 12 years and older with solid tumors that (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and (ii) are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, (iii) have progressed following treatment or have no satisfactory alternative therapy. The FDA notes that 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 the confirmatory trials.", + "source_type": "FDA", + "citation": "Bristol-Myers Squibb Company. 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 July 11, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218213s001lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-06-13", + "last_updated": "2024-07-11", + "_deprecated": false, + "feature_display": "NTRK1 Fusion" + }, + { + "feature_type": "Rearrangement", + "gene1": "NTRK2", + "gene2": "", + "rearrangement_type": "Fusion", + "locus": "", + "disease": "Any solid tumor", + "context": "", + "oncotree_term": "Any solid tumor", + "oncotree_code": "", + "therapy_name": "Repotrectinib", + "therapy_strategy": "TRK 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 repotrectinib for the treatment of adult and pediatric patients of age 12 years and older with solid tumors that (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and (ii) are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, (iii) have progressed following treatment or have no satisfactory alternative therapy. The FDA notes that 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 the confirmatory trials.", + "source_type": "FDA", + "citation": "Bristol-Myers Squibb Company. 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 July 11, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218213s001lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-06-13", + "last_updated": "2024-07-11", + "_deprecated": false, + "feature_display": "NTRK2 Fusion" + }, + { + "feature_type": "Rearrangement", + "gene1": "NTRK3", + "gene2": "", + "rearrangement_type": "Fusion", + "locus": "", + "disease": "Any solid tumor", + "context": "", + "oncotree_term": "Any solid tumor", + "oncotree_code": "", + "therapy_name": "Repotrectinib", + "therapy_strategy": "TRK 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 repotrectinib for the treatment of adult and pediatric patients of age 12 years and older with solid tumors that (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and (ii) are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, (iii) have progressed following treatment or have no satisfactory alternative therapy. The FDA notes that 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 the confirmatory trials.", + "source_type": "FDA", + "citation": "Bristol-Myers Squibb Company. 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 July 11, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218213s001lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-06-13", + "last_updated": "2024-07-11", + "_deprecated": false, + "feature_display": "NTRK3 Fusion" + }, + { + "feature_type": "Somatic Variant", + "gene": "KRAS", + "chromosome": "12", + "start_position": 25398285, + "end_position": 25398285, + "reference_allele": "C", + "alternate_allele": "A", + "cdna_change": "c.34G>T", + "protein_change": "p.G12C", + "variant_annotation": "Missense", + "exon": 2, + "rsid": "rs121913530", + "disease": "Colorectal Cancer", + "context": "", + "oncotree_term": "Colorectal Adenocarcinoma", + "oncotree_code": "COADREAD", + "therapy_name": "Adagrasib + Cetuximab", + "therapy_strategy": "RAS inhibition + 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 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 FDA notes that this indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval of this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.", + "source_type": "FDA", + "citation": "Mirati Therapeutics, Inc. Krazati (adagrasib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216340s005lbl.pdf. Revised June 2024. Accessed July 11, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216340s005lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-06-21", + "last_updated": "2024-07-11", + "_deprecated": false, + "feature_display": "KRAS p.G12C (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": "", + "end_position": "", + "reference_allele": "", + "alternate_allele": "", + "cdna_change": "", + "protein_change": "", + "variant_annotation": "", + "exon": "", + "rsid": "", + "disease": "Astrocytoma", + "context": "", + "oncotree_term": "Astrocytoma", + "oncotree_code": "ASTR", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": 209113113, + "end_position": 209113113, + "reference_allele": "G", + "alternate_allele": "A", + "cdna_change": "c.394C>T", + "protein_change": "p.R132C", + "variant_annotation": "Missense", + "exon": 4, + "rsid": "rs121913499", + "disease": "Astrocytoma", + "context": "", + "oncotree_term": "Astrocytoma", + "oncotree_code": "ASTR", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1 p.R132C (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": 209113113, + "end_position": 209113113, + "reference_allele": "G", + "alternate_allele": "C", + "cdna_change": "c.394C>G", + "protein_change": "p.R132G", + "variant_annotation": "Missense", + "exon": "4", + "rsid": "rs121913499", + "disease": "Astrocytoma", + "context": "", + "oncotree_term": "Astrocytoma", + "oncotree_code": "ASTR", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1 p.R132G (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": 209113112, + "end_position": 209113112, + "reference_allele": "C", + "alternate_allele": "T", + "cdna_change": "c.395G>A", + "protein_change": "p.R132H", + "variant_annotation": "Missense", + "exon": 4, + "rsid": "rs121913500", + "disease": "Astrocytoma", + "context": "", + "oncotree_term": "Astrocytoma", + "oncotree_code": "ASTR", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1 p.R132H (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": 209113112, + "end_position": 209113112, + "reference_allele": "C", + "alternate_allele": "A", + "cdna_change": "c.395G>T", + "protein_change": "p.R132L", + "variant_annotation": "Missense", + "exon": 4, + "rsid": "rs121913500", + "disease": "Astrocytoma", + "context": "", + "oncotree_term": "Astrocytoma", + "oncotree_code": "ASTR", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1 p.R132L (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": 209113113, + "end_position": 209113113, + "reference_allele": "G", + "alternate_allele": "T", + "cdna_change": "c.394C>A", + "protein_change": "p.R132S", + "variant_annotation": "Missense", + "exon": "4", + "rsid": "rs121913499", + "disease": "Astrocytoma", + "context": "", + "oncotree_term": "Astrocytoma", + "oncotree_code": "ASTR", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1 p.R132S (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH2", + "chromosome": "15", + "start_position": "", + "end_position": "", + "reference_allele": "", + "alternate_allele": "", + "cdna_change": "", + "protein_change": "", + "variant_annotation": "", + "exon": "", + "rsid": "", + "disease": "Astrocytoma", + "context": "", + "oncotree_term": "Astrocytoma", + "oncotree_code": "ASTR", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH2" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH2", + "chromosome": "15", + "start_position": 90631837, + "end_position": 90631837, + "reference_allele": "C", + "alternate_allele": "T", + "cdna_change": "c.515G>A", + "protein_change": "p.R172K", + "variant_annotation": "Missense", + "exon": 4, + "rsid": "rs121913503", + "disease": "Astrocytoma", + "context": "", + "oncotree_term": "Astrocytoma", + "oncotree_code": "ASTR", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH2 p.R172K (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH2", + "chromosome": "15", + "start_position": 90631839, + "end_position": 90631839, + "reference_allele": "T", + "alternate_allele": "C", + "cdna_change": "c.514A>G", + "protein_change": "p.R172G", + "variant_annotation": "Missense", + "exon": 4, + "rsid": "rs1057519906", + "disease": "Astrocytoma", + "context": "", + "oncotree_term": "Astrocytoma", + "oncotree_code": "ASTR", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH2 p.R172G (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": "", + "end_position": "", + "reference_allele": "", + "alternate_allele": "", + "cdna_change": "", + "protein_change": "", + "variant_annotation": "", + "exon": "", + "rsid": "", + "disease": "Oligodendroglioma", + "context": "", + "oncotree_term": "Oligodendroglioma", + "oncotree_code": "ODG", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": 209113113, + "end_position": 209113113, + "reference_allele": "G", + "alternate_allele": "A", + "cdna_change": "c.394C>T", + "protein_change": "p.R132C", + "variant_annotation": "Missense", + "exon": 4, + "rsid": "rs121913499", + "disease": "Oligodendroglioma", + "context": "", + "oncotree_term": "Oligodendroglioma", + "oncotree_code": "ODG", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1 p.R132C (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": 209113113, + "end_position": 209113113, + "reference_allele": "G", + "alternate_allele": "C", + "cdna_change": "c.394C>G", + "protein_change": "p.R132G", + "variant_annotation": "Missense", + "exon": "4", + "rsid": "rs121913499", + "disease": "Oligodendroglioma", + "context": "", + "oncotree_term": "Oligodendroglioma", + "oncotree_code": "ODG", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1 p.R132G (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": 209113112, + "end_position": 209113112, + "reference_allele": "C", + "alternate_allele": "T", + "cdna_change": "c.395G>A", + "protein_change": "p.R132H", + "variant_annotation": "Missense", + "exon": 4, + "rsid": "rs121913500", + "disease": "Oligodendroglioma", + "context": "", + "oncotree_term": "Oligodendroglioma", + "oncotree_code": "ODG", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1 p.R132H (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": 209113112, + "end_position": 209113112, + "reference_allele": "C", + "alternate_allele": "A", + "cdna_change": "c.395G>T", + "protein_change": "p.R132L", + "variant_annotation": "Missense", + "exon": 4, + "rsid": "rs121913500", + "disease": "Oligodendroglioma", + "context": "", + "oncotree_term": "Oligodendroglioma", + "oncotree_code": "ODG", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1 p.R132L (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH1", + "chromosome": "2", + "start_position": 209113113, + "end_position": 209113113, + "reference_allele": "G", + "alternate_allele": "T", + "cdna_change": "c.394C>A", + "protein_change": "p.R132S", + "variant_annotation": "Missense", + "exon": "4", + "rsid": "rs121913499", + "disease": "Oligodendroglioma", + "context": "", + "oncotree_term": "Oligodendroglioma", + "oncotree_code": "ODG", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH1 p.R132S (Missense)" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH2", + "chromosome": "15", + "start_position": "", + "end_position": "", + "reference_allele": "", + "alternate_allele": "", + "cdna_change": "", + "protein_change": "", + "variant_annotation": "", + "exon": "", + "rsid": "", + "disease": "Oligodendroglioma", + "context": "", + "oncotree_term": "Oligodendroglioma", + "oncotree_code": "ODG", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH2" + }, + { + "feature_type": "Somatic Variant", + "gene": "IDH2", + "chromosome": "15", + "start_position": 90631837, + "end_position": 90631837, + "reference_allele": "C", + "alternate_allele": "T", + "cdna_change": "c.515G>A", + "protein_change": "p.R172K", + "variant_annotation": "Missense", + "exon": 4, + "rsid": "rs121913503", + "disease": "Oligodendroglioma", + "context": "", + "oncotree_term": "Oligodendroglioma", + "oncotree_code": "ODG", + "therapy_name": "Vorasidenib", + "therapy_strategy": "IDH 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 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. This approval is based on INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial. IDH mutation status was determined using Oncomine Dx Target Test to confirm detection of IDH1 mutation variants (p.R132H, p.R132C, p.R132G, p.R132S, or p.R132L) and IDH2 mutation variants (p.R172K, p.R172M, p.R172W, p.R172S, or p.R172G). Within the vorasidenib arm of the trial, they observed 163 patients that were IDH1-positive and 5 that were IDH2-positive with the amino acid changes of: IDH1 p.R132C (8), p.R132G (5), p.R132H (146), p.R132L (2), p.R132S (2), and IDH2 p.R172K (5) and p.R172G (2).", + "source_type": "FDA", + "citation": "Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-06", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "IDH2 p.R172K (Missense)" + }, + { + "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": "", + "oncotree_term": "Non-Small Cell Lung Cancer", + "oncotree_code": "NSCLC", + "therapy_name": "Amivantamab-vmjw + Lazertinib", + "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 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.", + "source_type": "FDA", + "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. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219008s000lbledt.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-19", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "EGFR p.L858R (Missense)" + }, + { + "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": "", + "oncotree_term": "Non-Small Cell Lung Cancer", + "oncotree_code": "NSCLC", + "therapy_name": "Amivantamab-vmjw + Lazertinib", + "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 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.", + "source_type": "FDA", + "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. Accessed September 3, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219008s000lbledt.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-08-19", + "last_updated": "2024-09-03", + "_deprecated": false, + "feature_display": "EGFR Exon 19 (Deletion)" + }, + { + "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": "", + "oncotree_term": "Non-Small Cell Lung Cancer", + "oncotree_code": "NSCLC", + "therapy_name": "Amivantamab-vmjw + Carboplatin + Pemetrexed", + "therapy_strategy": "EGFR inhibition + Platinum-based chemotherapy + Antifolate", + "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 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 p.L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.", + "source_type": "FDA", + "citation": "Janssen Biotech, Inc. Rybrevant (amivantamab-vmjw) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s004lbl.pdf. Revised September 2024. Accessed October 2, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s004lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-09-19", + "last_updated": "2024-10-02", + "_deprecated": false, + "feature_display": "EGFR p.L858R (Missense)" + }, + { + "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": "", + "oncotree_term": "Non-Small Cell Lung Cancer", + "oncotree_code": "NSCLC", + "therapy_name": "Amivantamab-vmjw + Carboplatin + Pemetrexed", + "therapy_strategy": "EGFR inhibition + Platinum-based chemotherapy + Antifolate", + "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 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 p.L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.", + "source_type": "FDA", + "citation": "Janssen Biotech, Inc. Rybrevant (amivantamab-vmjw) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s004lbl.pdf. Revised September 2024. Accessed October 2, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s004lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-09-19", + "last_updated": "2024-10-02", + "_deprecated": false, + "feature_display": "EGFR Exon 19 (Deletion)" + }, + { + "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": "", + "oncotree_term": "Non-Small Cell Lung Cancer", + "oncotree_code": "NSCLC", + "therapy_name": "Osimertinib", + "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 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 p.L858R mutations, as detected by an FDA-approved test.", + "source_type": "FDA", + "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 2, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-09-25", + "last_updated": "2024-10-02", + "_deprecated": false, + "feature_display": "EGFR Exon 19 (Deletion)" + }, + { + "feature_type": "Somatic Variant", + "gene": "EGFR", + "chromosome": "7", + "start_position": 55249071, + "end_position": 55249071, + "reference_allele": "C", + "alternate_allele": "T", + "cdna_change": "c.2369C>T", + "protein_change": "p.T790M", + "variant_annotation": "Missense", + "exon": 20, + "rsid": "rs121434569", + "disease": "Non-Small Cell Lung Cancer", + "context": "Metastatic", + "oncotree_term": "Non-Small Cell Lung Cancer", + "oncotree_code": "NSCLC", + "therapy_name": "Osimertinib", + "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 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 p.L858R mutations, as detected by an FDA-approved test.", + "source_type": "FDA", + "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 2, 2024.", + "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf", + "doi": "", + "pmid": "", + "nct": "", + "publication_date": "2024-09-25", + "last_updated": "2024-10-02", + "_deprecated": false, + "feature_display": "EGFR p.T790M (Missense)" } ] } \ No newline at end of file diff --git a/docs/template-pull-request.md b/docs/pull_request_template.md similarity index 100% rename from docs/template-pull-request.md rename to docs/pull_request_template.md diff --git a/moalmanac/config.ini b/moalmanac/config.ini index 8b5c7d5..16c28cf 100644 --- a/moalmanac/config.ini +++ b/moalmanac/config.ini @@ -14,7 +14,7 @@ level = INFO [versions] interpreter = 0.7.2 -database = v.2024-04-11 +database = v.2024-10-03 [exac] exac_common_af_threshold = 0.001