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2024 January 11 release (#24)
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7 changes: 7 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.

## January 2024 release
Added entries:
- (FDA) _ERBB2_ amplification and sensitivity to neratinib in combination with capecitabine for patients with breast cancer.

Revised entries:
- (FDA) _ERBB2_ amplification and sensitivity to neratinib for patients with breast cancer, received an updated description and citation.

## December 2023 release
Added entries:
- (FDA) _PIK3CA_ and _AKT_ somatic variants and _PTEN_ loss of function variants and sensitivity to capivasertib in combination with fulvestrant for patients with breast cancer.
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12 changes: 6 additions & 6 deletions docs/sop.md
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Expand Up @@ -99,7 +99,7 @@ The PDF should be saved as `{revised year}-{revised month}-{generic drug name}.p

You can stay up to date on FDA approvals by visiting or subscribing to:
- [FDA press announcements](https://www.fda.gov/news-events/fda-newsroom/press-announcements)
- [FDA Hematology/Oncology (Cancer) Approvals & Safety Notifications](https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications), a summary list of all approvals by year.
- [FDA Hematology/Oncology (Cancer) Approvals & Safety Notifications](https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications), a summary list of all approvals by date.
- [FDA Oncology on Twitter (@FDAOncology)](https://twitter.com/FDAOncology)

###### Fields
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- `last_updated`, with the last updated time
- `doi`, `pmid`, and `nct` will be left blank

The description for guidelines should brief readers on the assertion(s) made in the publication. For example,
> Translocations predict sensitivity to tyrosine kinase inhibitors such as imatinib, dasatinib, and nilotinib. Secondary mutations can cause resistance to these agents. Dasatinib or Bosutinib are second-line and subsequent therapies for cytogenetic or hematologic resistance to TKIs.
The description for guidelines should brief readers on the relationship, following the [NCCN's referencing guidance](https://www.nccn.org/docs/default-source/business-policy/nccn-referencing-guidance.pdf),
> [Generic name (brand name)] is recommended by the National Comprehensive Cancer Network® (NCCN®) as a treatment option for [setting and cancer type]
The citation for guidelines should follow the [American Medical Association (AMA)](https://mdanderson.libanswers.com/faq/26180) style format:
> {Source}. {Tumor type} (Version {version number}.{year}). {URL}. Accessed {month date} {day date}, {year date}.
The citation for guidelines should follow the [NCCN's referencing guidance](https://www.nccn.org/docs/default-source/business-policy/nccn-referencing-guidance.pdf):
> Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Guideline Name V.X.202X. © National Comprehensive Cancer Network, Inc. 202X. All rights reserved. Accessed Month and Day, Year]. To view the most recent and complete version of the guideline, go online to NCCN.org.
For example,
> National Comprehensive Cancer Network. Chronic Myelogenous Leukemia (Version 1.2016). https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf. Accessed November 5, 2016.
> Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed November 2, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
[Return to Table of Contents](#table-of-contents)

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64 changes: 45 additions & 19 deletions molecular-oncology-almanac.json
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"therapy_resistance": "",
"favorable_prognosis": "",
"predictive_implication": "FDA-Approved",
"description": "The U.S. Food and Drug Administraton (FDA) granted accelerated approval to Pemazyre (pemigatinib). Pemigatinib is a kinase inhibitor indicated for the treatment of adults with previously treated, unresctable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test.",
"description": "The U.S. Food and Drug Administraton (FDA) granted accelerated approval to Pemazyre (pemigatinib). Pemigatinib is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test.",
"source_type": "FDA",
"citation": "Incyte Corporation. Pemazyre (pemigatinib) [package insert]. U.S. Food and Drug Administration website. www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf. Revised April 2020. Accessed October 15th, 2020.",
"url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf",
Expand All @@ -826,7 +826,7 @@
"therapy_resistance": "",
"favorable_prognosis": "",
"predictive_implication": "FDA-Approved",
"description": "The U.S. Food and Drug Administraton (FDA) granted accelerated approval to Pemazyre (pemigatinib). Pemigatinib is a kinase inhibitor indicated for the treatment of adults with previously treated, unresctable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test.",
"description": "The U.S. Food and Drug Administraton (FDA) granted accelerated approval to Pemazyre (pemigatinib). Pemigatinib is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test.",
"source_type": "FDA",
"citation": "Incyte Corporation. Pemazyre (pemigatinib) [package insert]. U.S. Food and Drug Administration website. www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf. Revised April 2020. Accessed October 15th, 2020.",
"url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf",
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"exon": 15,
"rsid": "rs113488022",
"disease": "Melanoma",
"context": "Unresctable or metastatic",
"context": "Unresectable or metastatic",
"oncotree_term": "Melanoma",
"oncotree_code": "MEL",
"therapy_name": "Dabrafenib",
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"exon": 15,
"rsid": "rs113488022",
"disease": "Melanoma",
"context": "Unresctable or metastatic",
"context": "Unresectable or metastatic",
"oncotree_term": "Melanoma",
"oncotree_code": "MEL",
"therapy_name": "Dabrafenib + Trametinib",
Expand Down Expand Up @@ -4515,7 +4515,7 @@
"exon": 15,
"rsid": "rs121913227",
"disease": "Melanoma",
"context": "Unresctable or metastatic",
"context": "Unresectable or metastatic",
"oncotree_term": "Melanoma",
"oncotree_code": "MEL",
"therapy_name": "Dabrafenib + Trametinib",
Expand Down Expand Up @@ -4651,7 +4651,7 @@
"exon": 15,
"rsid": "rs113488022",
"disease": "Melanoma",
"context": "Unresctable or metastatic",
"context": "Unresectable or metastatic",
"oncotree_term": "Melanoma",
"oncotree_code": "MEL",
"therapy_name": "Trametinib",
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"exon": 15,
"rsid": "rs121913227",
"disease": "Melanoma",
"context": "Unresctable or metastatic",
"context": "Unresectable or metastatic",
"oncotree_term": "Melanoma",
"oncotree_code": "MEL",
"therapy_name": "Trametinib",
Expand Down Expand Up @@ -4719,7 +4719,7 @@
"exon": 15,
"rsid": "rs121913227",
"disease": "Melanoma",
"context": "Unresctable or metastatic",
"context": "Unresectable or metastatic",
"oncotree_term": "Melanoma",
"oncotree_code": "MEL",
"therapy_name": "Encorafenib",
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"exon": 15,
"rsid": "rs113488022",
"disease": "Melanoma",
"context": "Unresctable or metastatic",
"context": "Unresectable or metastatic",
"oncotree_term": "Melanoma",
"oncotree_code": "MEL",
"therapy_name": "Encorafenib",
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"exon": 15,
"rsid": "rs113488022",
"disease": "Melanoma",
"context": "Unresctable or metastatic",
"context": "Unresectable or metastatic",
"oncotree_term": "Melanoma",
"oncotree_code": "MEL",
"therapy_name": "Vemurafenib",
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"exon": "",
"rsid": "",
"disease": "Gastrointestinal Stromal Tumor",
"context": "Unresctable and/or metastatic",
"context": "Unresectable and/or metastatic",
"oncotree_term": "Gastrointestinal Stromal Tumor",
"oncotree_code": "GIST",
"therapy_name": "Imatinib",
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"exon": 18,
"rsid": "",
"disease": "Gastrointestinal Stromal Tumor",
"context": "Unresctable or metastatic",
"context": "Unresectable or metastatic",
"oncotree_term": "Gastrointestinal Stromal Tumor",
"oncotree_code": "GIST",
"therapy_name": "Avapritinib",
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"exon": 18,
"rsid": "rs121908585",
"disease": "Gastrointestinal Stromal Tumor",
"context": "Unresctable or metastatic",
"context": "Unresectable or metastatic",
"oncotree_term": "Gastrointestinal Stromal Tumor",
"oncotree_code": "GIST",
"therapy_name": "Avapritinib",
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"therapy_resistance": "",
"favorable_prognosis": "",
"predictive_implication": "FDA-Approved",
"description": "Neratinib is indicated for extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy",
"description": "The U.S. Food and Drug Administration (FDA) approved neratinib as a single agent for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy.",
"source_type": "FDA",
"citation": "Pfizer, Inc. Lorbrena (lorlatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210868s001lbl.pdf. Revised May 2020. Accessed November 12, 2020.",
"url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210868s001lbl.pdf",
"citation": "Puma Biotechnology, Inc. Nerlynx (neratinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208051s009lbl.pdf. Revised June 2021. Accessed January 11, 2024.",
"url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208051s009lbl.pdf",
"doi": "",
"pmid": "",
"nct": "",
"publication_date": "2020-05-01",
"last_updated": "2020-11-12"
"publication_date": "2017-07-17",
"last_updated": "2024-01-11"
},
{
"feature_type": "Copy Number",
Expand Down Expand Up @@ -27980,7 +27980,7 @@
"exon": 15,
"rsid": "rs113488022",
"disease": "Low-grade glioma",
"context": "Unresctable or metastatic",
"context": "Unresectable or metastatic",
"oncotree_term": "Low-Grade Glioma, NOS",
"oncotree_code": "LGGNOS",
"therapy_name": "Dabrafenib + Trametinib",
Expand Down Expand Up @@ -30524,5 +30524,31 @@
"nct": "",
"publication_date": "2023-11-16",
"last_updated": "2023-12-07"
},
{
"feature_type": "Copy Number",
"gene": "ERBB2",
"direction": "Amplification",
"cytoband": "",
"disease": "Breast Cancer",
"context": "Advanced or metastatic",
"oncotree_term": "Invasive Breast Carcinoma",
"oncotree_code": "BRCA",
"therapy_name": "Neratinib + Capecitabine",
"therapy_strategy": "ER signaling inhibition + Thymidylate synthase inhibitor",
"therapy_type": "Targeted therapy + Chemotherapy",
"therapy_sensitivity": 1,
"therapy_resistance": "",
"favorable_prognosis": "",
"predictive_implication": "FDA-Approved",
"description": "The U.S. Food and Drug Administration (FDA) approved neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.",
"source_type": "FDA",
"citation": "Puma Biotechnology, Inc. Nerlynx (neratinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208051s009lbl.pdf. Revised June 2021. Accessed January 11, 2024.",
"url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210868s001lbl.pdf",
"doi": "",
"pmid": "",
"nct": "",
"publication_date": "2020-02-25",
"last_updated": "2024-01-11"
}
]

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