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2024 July 11 release (#29)
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brendanreardon authored Jul 11, 2024
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8 changes: 8 additions & 0 deletions docs/content-changelog.md
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# Content Changelog
The following changes have been made to the content catalogued within the Molecular Oncology Almanac knowledge base.

## July 2024 release
Added entries:
- (FDA) _KRAS_ p.G12C and sensitivity to adagrasib in combination with cetuximab for patients with colorectal cancer received accelerated approval.
- (FDA) _NTRK1/2/3_ gene fusions and sensitivity to repotrectinib for patients with solid tumors received accelerated approval.

Revised entries:
- (FDA) _RET_ fusions and sensitivity to selpercatinib for patients with thyroid cancer received traditional approval from the FDA, from accelerated approval.

## June 2024 release
Added entries:
- (FDA) _ALK_ fusions and sensitivity to alectinib for patients with non-small cell lung cancer.
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127 changes: 123 additions & 4 deletions molecular-oncology-almanac.json
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"predictive_implication": "FDA-Approved",
"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/2024/213246s012lbl.pdf. Revised May 2024. Accessed June 3, 2024.",
"url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.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": "2024-05-29",
"last_updated": "2024-06-03",
"publication_date": "2024-06-12",
"last_updated": "2024-07-11",
"_deprecated": false
},
{
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"publication_date": "2021-05-05",
"last_updated": "2024-06-03",
"_deprecated": false
},
{
"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_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_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_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
}
]

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