2026 May 7th release

This Release contains updates to the draft version of the database. Concept mappings to RxNorm, SNOMED, and OMOP are now present for all curated therapies. We additionally curate an approval for imlunestrant from the European Medicines Agency, as well as another for belzutifan from both the European Medicines Agency and Food and Drug Administration.

Database content updates

Added entries:

• (EMA) ER+, HER2-negative, and ERBB2 activating variants and sensitivity to imlunestrant for patients with breast cancer.
• (EMA, FDA) VHL pathogenic variants and sensitivity to belzutifan for patients with renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors.

Revised entries:

• (FDA) TSC1/2 oncogenic variants and sensitivity to everolimus for patients with subependymal giant cell astrocytoma was previously incorrectly associated with a different cancer type. A coding for subependymal giant cell astrocytoma was introduced and these TSC1/2 relationships were updated.
• The initial approval date for all EMA indications was updated to reflect the European Commission approval date, rather than the publication date of referenced documents.
• All therapies now include mappings to RxNorm, SNOMED, and OMOP, with the exception of 34 which were only represented in either RxNorm or SNOMED but not both.

What's Changed

• added therapies.dereferenced.json file by @ehahn25 in #126
• Updated EMA initial approval dates to match European Commission Dates by @brendanreardon in #127
• Refactor dereference by @brendanreardon in #130
• Include RxNorm, SNOMED, and OMOP mappings by @brendanreardon in #131
• 2026 May EMA & FDA updates by @brendanreardon in #133

New Contributors

• @ehahn25 made their first contribution in #126

Full Changelog: v.2026-04-09...v.2026-05-07

2026 April 9th release

This release contains updates to the draft version of the database. EGFR TKD activating variants was introduced as a biomarker and associated with regulatory approvals from the European Medicines Agency (EMA) and Health Canada (HC). No additional genomic knowledge statements were added with this release, though several were modified.

Database content updates

Added entries:

• (EMA, HC) EGFR TKD activating variants and response to gefitinib for patients with non-small cell lung cancer.

Revised entries:

• (FDA) A description was previously not written for Statements associated with Indication ind:fda.kadcyla:0.
• (FDA) The text for ind:fda.augtyro:1 was revised to resolve typos.
• (HSE) The URLs were updated for all documents originating from Ireland's Health Service Executive (HSE) to reflect their new website.
• (HSE) ids associated with treatment regimen "P0567" from the HSE were updated to be "P00567".
• Biomarker names for EGFR, ERBB2, and ESR1 oncogenic variants were renamed to "activating variants" to align with the scope of the associated regulatory approvals.

New features

• Badges in the moalmanac-db README are now hard coded and do not rely on an API request to render.

What's Changed

• Update badges by @brendanreardon in #123
• Update biomarker names by @brendanreardon in #124
• Update HSE urls by @brendanreardon in #125

Full Changelog: v.2026-03-05...v.2026-04-09

2026 March 5th release

This release contains updates to the draft version of the database with FDA precision oncology approvals from February 2026. Specifically, indications and derived relationships were updated for Braftovi (encorafenib), Hernexeos (zongertinib), and Keytruda (pembrolizumab).

Database content updates

Added entries:

• (FDA) BRAF p.V600E and sensitivity to encorafenib in combination with cetuximab and FOLFIRI for patients with metastatic colorectal cancer.
• (FDA) PD-L1 (CPS >= 1) and sensitivity to pembrolizumab in combination with paclitaxel, with or without bevacizumab, for patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

Revised entries:

• (FDA) BRAF p.V600E and sensitivity to encorafenib in combination with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer received regular approval.
• (FDA) ERBB2 activating variants and sensitivity to zongertinib in patients with non-squamous non-small cell lung cancer was revised to expand treatment eligibility by removing the prior therapy restriction.

Removed entries:

• (EMA, HSE) FGFR2::BICC1 and FGFR2::CASP7 and sensitivity to erdafitinib in patients with bladder urothelial carcinoma.

New features

• The Documents table was merged to align with VA-Spec.
• URLs associated with documents have been moved to their own table in the referenced/ folder

What's Changed

• Adjust initial approval dates by @brendanreardon in #114
• Refactor documents by @brendanreardon in #115
• Url table by @brendanreardon in #116
• Ema hse adjustments by @brendanreardon in #118
• 2026-03-02 FDA updates by @brendanreardon in #120
• Updated last_updated dates and PR template by @brendanreardon in #121

Full Changelog: v.2026-02-05...v.2026-03-05

2026 February 2nd release

This release contains updates to the draft version of the database with FDA precision oncology approvals for Akeega. Additionally, the Organizations table was merged into the Agents table.

Database content updates

Added entries:

• (FDA) BRCA2 oncogenic and pathogenic variants and sensitivity to niraparib and abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-sensitive prostate cancer.

Revised entries:

• (FDA) BRCA1/2 oncogenic and pathogenic variants and sensitivity to niraparib and abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer was incorrectly listed as initially published in 2018 instead of 2023.

New features

• The description written for each statement associated with an indication from the indications table will now populate the description field when dereferencing the database.
• The Agents and Organizations table were merged to align with VA-Spec.

What's Changed

• Apply indication description to statement, if populated by @brendanreardon in #109
• Merge Organizations and Agents tables by @brendanreardon in #110
• Akeega FDA approvals by @brendanreardon in #111

Full Changelog: v.2025-12-26...v.2026-02-05

2025 December 26th release

This release contains updates to the current and draft versions of the database with FDA precision oncology approvals from October, November, and December 2025.

Database content updates

Added entries:

• (FDA) Activating ERBB2 TKD variants and sensitivity to sevabertinib for patients with non-squamous NSCLC (in development version only).
• (FDA) HER2 negative and PD-L1 >= 1 and sensitivity to tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy for patients with gastric or gastroesophageal junction adenocarcinoma (in development version only).
• (FDA) HER2 positive and sensitivity to trastuzumab deruxtecan in combination with pembrolizumab for patients with unresectable or metastatic breast cancer (in development version only).
• (FDA) NPM1 p.W288Cfs*12 and sensitivity to revumenib for patients with acute leukemias.
• (FDA) NPM1 p.W288Cfs*12 and sensitivity to ziftomenib for patients with acute myeloid leukemia.
• (FDA) PD-L1 >= 1 and sensitivity to tislelizumab in combination with platinum-containing chemotherapy for patients with esophageal squamous cell carcinoma (in development version only).

Revised entries:

• (FDA) BRCA1/2 mutated mCRPC and sensitivity to rucaparib received regular approval after receiving accelerated approval in 2020 (in development version only).

What's Changed

• HSE & HPRA by @brendanreardon in #98
• Additional hse by @brendanreardon in #99
• HSE adjustments by @brendanreardon in #100
• Ema dates by @brendanreardon in #102
• 2025-12-26 database release by @brendanreardon in #108

Full Changelog: v.2025-10-03...v.2025-12-26

2025 October 3rd release

This Release contains derived relationships for several previously curated indications that did not have derived statements. It also includes curations for previously missed FDA approvals for quizartinib and ibrutinib. These changes were only made to the in development version of the database. These gaps were identified by @hjjshine 🌟

What's Changed

• Deriving relationships for dangling approvals by @brendanreardon in #96

Full Changelog: v.2025-10-02...v.2025-10-03

2025 October 2nd release

This release contains updates to the current and draft versions of the database with FDA and EMA precision oncology approvals from September 2025.

Database content updates

Added entries:

• (FDA) Dordaviprone for the treatment of adult and pediatric patients with H3-3A:c.83A>T p.K28M (K27M) diffuse midline glioma.
• (FDA) Imlunestrant for treatment of patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer (in development version only).
• (EMA) Vorasidenib for the treatment of patients with astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation (in development version only).
• (EMA) Added document records for Itovebi (inavolisib) and Ziihera (zanidatamab) (in development version only).

Revised entries:

• (FDA) Four statements derived from FDA approvals for Akeega were associated with incorrect biomarkers instead of germline and somatic BRCA1/2.
• (FDA) The citation and implication for sunvozertinib and EGFR exon 20 insertions were incorrectly listed.
• Three codings incorrectly pointed to an incorrect url (in development version only).
• The following genes were missing RefSeq mappings and location extensions: ATR, FANCA, KMT2A, MLH1, MRE11, NBN, TSC1, TSC2, (in development version only).

What's Changed

• 2025 October 2nd release by @brendanreardon in #95

Full Changelog: v.2025-09-04...v.2025-10-02

2025 September 4th release

This release contains updates to the current and draft versions of the database with FDA oncology approvals from June, July, and August 2025. The change log local to this repository has been removed and pointers now direct to news.moalmanac.org. Release notes will also continue to be available through this repository's Releases.

Database content updates

Added entries:

• (FDA) Datopotamab deruxtecan for the treatment of adult patients with locally advanced or metastatic EGFR mutated non-small cell lung cancer.
• (FDA) Datopotamab deruxtecan for the treatment of adult patients with unresectable or metastatic, HR+, HER2-negative breast cancer (in development version only).
• (FDA) Pembrolizumab for the treatment of patients with head and neck squamous cell cancer with PD-L1 (CPS) >= 1 (in development version only).
• (FDA) Sunvozertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations.
• (FDA) Zongertinib for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations (in development version only).

What's Changed

• Move tests to pytest, sanitized database for duplicates by @brendanreardon in #78
• Bug fix: dereferencing by @brendanreardon in #79
• Health Canada draft by @brendanreardon in #80
• Modification to hc update by @brendanreardon in #81
• Formatting fixes for CA documents and statements by @brendanreardon in #82
• Duplicate therapy groups by @brendanreardon in #87
• 2025 September 4th release by @brendanreardon in #86

Full Changelog: v.2025-06-12...v.2025-09-04

2025 June 12th release

Updated current and draft version of the database with FDA oncology approvals from May and June, thus far, 2025.

Database content updates

Added entries:

• (FDA) Taletrectinib for the treatment of patients with ROS1-positive non-small cell lung cancer.
• (FDA) Telisotuzumab vedotin for the treatment of patients with high c-Met protein overexpression non-squamous non-small cell lung cancer.
• (FDA) Avutometinib in combination with defactinib for the treatment of patients with KRAS-mutant low-grade serous ovarian cancer (G12C, G12V).

What's Changed

• Rename id for documents, indications, and organizations by @brendanreardon in #71
• 2025-06-12 release by @brendanreardon in #73
• 2025 06 12 2 by @brendanreardon in #75

Full Changelog: v.2025-05-01...v.2025-06-12

2025 May 1st release

Updated current and draft version of the database with FDA oncology approvals from April 2025.

A few pull requests were completed for the work in progress version of the database:

• Pull request #64: "Expand upon approvals for abemaciclib in combination with endocrine therapy"
• Pull request #65: "Represent therapies with therapy groups"
• Pull request #66: "Reference codings and mappings"
• Pull request #67: "Replaced empty strings with null, added a missed contribution date"

Database content updates

Revised entries:

• (FDA) Pembrolizumab in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with HER2-positive gastric adenocarcinoma received traditional FDA approval after previously receiving accelerated approval. The FDA's product label from March 19th incorrectly still labeled this approval as an accelerated approval, they withdrew it and uploaded a corrected label on April 21st.
• (FDA) Nivolumab in combination with ipilimumab for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer received regular approval from the FDA after receiving accelerated approval in July 2018.
• (FDA) Nivolumab as a single agent for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan containing chemotherapy received regular approval from the FDA after receiving accelerated approval in July 2018.
• (FDA) Larotrectinib for the treatment of adult and pediatric patients with solid tumors with NTRK fusions received regular approval from the FDA, after receiving accelerated approval in November 2018.