2022 July 7 release

Added entries:

• (FDA) BRAF p.V600E and sensitivity to dabrafenib in combination with trametinib in any solid tumor.
• (FDA) IDH1 p.R132C, p.R132H and sensitivity to ivosidenib either with azacitidine or as a monotherapy in acute myeloid leukemia.
• (FDA) MSI-H and sensitivity to pembrolizumab in endometrial carcinoma.

2022 March 3 release

Revised entries:

• (FDA) KRAS p.G12C and sensitivity to sotorasib's description was revised to remove underscores.
• (Preclinical) KRAS somatic variants and sensitivity to FGFR1 inhibitor + trametinib was revised to remove a trailing space from the therapy name.

2021 November 4 release

Added entries:

• (FDA) BCR-ABL1 and sensitivity to asciminib in chronic phase chronic myeloid leukemia.
• (Clinical evidence) SPOP missense somatic variants and favorable prognosis in de-novo metastatic castration-sensitive prostate cancer.
• (Clinical evidence) SPOP missense somatic variants and sensitivity to abiraterone in metastatic castration-resistant prostate cancer
• (Clinical evidence) SPOP missense somatic variants and sensitivity to anti-androgen therapy.
• (Inferential) CD274 amplification and sensitivity to atezolizumab in non-small cell lung cancer.

Revised entries:

• (FDA) FGFR2 fusions and sensitivity to erdafitnib's description was revised to match the standard's described in our S.O.P..

2021 October 7 release

Added entries:

• (FDA) EGFR exon 20 insertion variants and sensitivity to mobocertinib in non-small cell lung cancer.

Revised entries:

• (FDA) BRCA1/2 pathogenic germline variants and sensitivity to talazoparib was revised to properly cite the package insert and correct a spelling error in the description.
• (FDA) BCR-ABL1 and sensitivity to bosutinib in chronic myelogenous leukemia was revised to update the hyperlink for the package insert.
• (FDA) BRAF p.V600E and sensitivity to encorafenib in melanoma was revised to update the hyperlink for the package insert.
• (FDA) TMB-High and sensitivity to pembrolizumab in any solid tumor was revised to correct a spelling error in the description.

2021 September 2 release

The following assertions sourced from recent FDA approvals were added to the Molecular Oncology Almanac in this release -

Added entries:

• (FDA) IDH1 p.R132C, p.R132H and sensitivity to ivosidenib in acute myeloid leukemia and cholangiocarcinoma.
• (FDA) IDH1 somatic variants and sensitivity to ivosidenib in acute myeloid leukemia and cholangiocarcinoma.
• (FDA) PDGFRA p.D842V and sensitivity to avapritinib in gastrointestinal stromal tumors.
• (Preclinical) KIT p.D816V and sensitivity to avapritinib in gastrointestinal stromal tumors.
• (Preclinical) KIT exon 11 and 17 somatic variants and sensitivity to avapritinib in gastrointestinal stromal tumors.
• (Preclinical) KIT somatic variants and sensitivity to avapritinib in mast cell leukemia.
• (Preclinical) PDGFRA p.D842V and sensitivity to avapritinib in gastrointestinal stromal tumors.
• (Preclinical) PDGFRA exon 18 somatic variants and sensitivity to avapritinib in gastrointestinal stromal tumors

Revised entries:

• (Guideline) PDGFRA p.842V and sensitivity to imatinib was revised to not sensitive.

2021 June 3 release

The following recent FDA approvals were added to the Molecular Oncology Almanac in this release -

Added entries:

• (FDA) EGFR exon 20 insertion somatic variants and sensitivity to amivantamab-vmjw in metastatic non-small cell lung cancer.
• (FDA) FGFR2 fusions and sensitivity to infigratinib in cholangiocarcinoma.
• (FDA) KRAS p.G12C and sensitivity to sotorasib in non-small cell lung cancer.

2021 May 6 release

The following changes were made to the Molecular Oncology Almanac in this release -

Added entries:

• (FDA) ERBB2 amplifications and sensitivity to pembrolizumab in combination with fluoropyrimidine, trastuzumab, and platinum-based chemotherapy in gastric or gastroesophageal junction adenocarcinoma.
• (Inferential) CD274 amplifications and sensitivity to pembrolizumab in gastric or gastroesophageal junction adenocarcinoma.

Edited entries:

• (Clinical evidence) NF1 germline variants associated with radiation therapy was not labeled with a clinical assertion. "1" has been set for adverse_event_risk.
• (Inferential) ERBB2 amplification and sensitivity to trastuzumab was changed to an inferential assertion from FDA. The description was also updated for these entries.

2021 February 4 release

In addition to the content changes listed below, this release added a therapeutic strategy (therapy_strategy) for all sensitive and resistance relationships.

Added entries:

• (FDA) EGFR p.L858R and sensitivity to osimertinib in non-small cell lung cancer.
• (FDA) EGFR exon 19 deletions and sensitivity to osimertinib in non-small cell lung cancer.
• (FDA) HER2-positive breast cancer and sensitivity to margetuximab-cmkb + chemotherapy.

Edited entries:

• (Guideline) ABL1 p.T315I suggesting sensitivity to Omacetaxine in CML has been recategorized from a targeted therapy to chemotherapy.
• (Guideline) MSI-High associated with resistance to 5-Fluorouracil in colorectal adenocarcinoma. 5-Fluorouracil was reclassified as a chemotherapy therapy type instead of targeted therapy.
• (Guideline) TET2 somatic variants suggesting sensitivity to azacitidine was changed from a targeted therapy to chemotherapy.
• (Clinical evidence) PAK1 amplifications associated with poor prognosis in breast cancer. Removed Tamoxifen from this association as it is not asserting therapeutic sensitivity or resistance.
• (Preclinical) KRAS somatic variants associated with sensitivity to trametinib + fgfr1 inhibition. Recorded therapy name to be alphabetical and changed inhibitor to be lowercase.
• (Preclinical) RUNX1--RUNX1T1 fusions and sensitivity to azacitidine + panobinostat has been reclassified as a combination therapy from targeted therapy.

Mutational signature version has been added as a feature definition for mutational signatures. All catalogued assertions of this feature type are currently using Mutational Signatures (v2).

Several assertions from clinical guideline sources for multiple myeloma and myelodysplasia were incorrectly reported as clinical evidence. These have been updated to be guidelines.

Removed entries:

2020 December 3 release

Added entries:

• (FDA) RET somatic variants associated with sensitivity to pralsetinib in advanced or metastatic medullary thyroid cancer.
• (FDA) RET fusions associated with sensitivity to pralsetinib in advanced or metastatic thyroid cancer.
• (Inferential) CDK274 amplifications associated with sensitivity to chemotherapy in combination with pembrolizumab in locally recurrent or metastatic triple-negative breast cancer.

Edited entries:

• (Guideline) CDK4 amplifications associated with sensitivity to palbociclib in well-differentiated and dedifferentiated liposarcoma, updated source.
• (Guideline) KIT somatic variants associated with sensitivity to sunitinib in thymic carcinomas, updated source.

Removed entries:

• (Preclinical) CDKN2B deletions associated with sensitivity to EPZ015666.

2020 November 12 release

This release focuses on FDA approvals since March 2020. In addition to the following changes, the citation style for all FDA approved associated have been updated to match American Medical Association (AMA) style formatting.

Added entries:

• (FDA) ATM somatic variants associated with sensitivity to olaparib in metastatic castration-resistant prostate cancer.
• (FDA) BARD1 somatic variants associated with sensitivity to olaparib in metastatic castration-resistant prostate cancer.
• (FDA) BRAF p.V600K, p.V600E associated with sensitivity to encorafenib in melanoma.
• (FDA) BRAF p.V600E associated with sensitivity to cetuximab + encorafenib in colorectal cancer.
• (FDA) BRCA1 and BRCA2 somatic and germline variants associated with sensitivity to olaparib in metastatic castration-resistant prostate cancer.
• (FDA) BRCA1 and BRCA2 somatic and germline variants associated with sensitivity to niraparib in ovarian, fallopian tube, and peritoneal cancer.
• (FDA) BRCA1 and BRCA2 somatic variants associated with sensitivity to bevacizumab and olaparib in advanced ovarian, fallopian tube, and peritoneal cancer.
• (FDA) BRIP1 somatic variants associated with sensitivity to olaparib in metastatic castration-resistant prostate cancer.
• (FDA) CD274 copy number amplifications associated with sensitivity to atezolizumab in non-small cell lung cancer.
• (FDA) CDK12 somatic variants associated with sensitivity to olaparib in metastatic castration-resistant prostate cancer.
• (FDA) CHEK1 and CHEK2 somatic variants associated with sensitivity to olaparib in metastatic castration-resistant prostate cancer.
• (FDA) ERBB2 copy number amplifications associated with sensitivity to capecitabine + trastuzumab + tucatinib in breast cancer.
• (FDA) ERBB2 copy number amplifications associated with sensitivity to chemotherapy + hyaluronidase-zzxf + pertuzumab + trastuzumab in breast cancer.
• (FDA) ERBB2 copy number amplifications associated with sensitivity to docetaxel + hyaluronidase-zzxf + pertuzumab + trastuzumab in metastatic breast cancer.
• (FDA) EZH2 p.Y646*, p.Y646F, p.Y646N, p.A682G, and p.A692V associated with sensitivity to tazemetostat in relapsed or refractory follicular lymphoma.
• (FDA) FANCL somatic variants associated with sensitivity to olaparib in metastatic castration-resistant prostate cancer.
• (FDA) FGFR2 fusions associated with sensitivity to pemigatinib in cholangiocarcinoma.
• (FDA) High-TMB (> 10 coding mutations per Mb) associated with sensitivity to pembrolizumab in any unresectable or metastatic solid tumor.
• (FDA) MET somatic splice site, deletion, and nonsense variants associated with sensitivity to capmatinib and crizotinib in non-small cell lung cancer.
• (FDA) PALB2 somatic variants associated with sensitivity to olaparib in metastatic castration-resistant prostate cancer.
• (FDA) RAD51B, RAD51C, RAD51D, and RAD51L somatic variants associated with sensitivity to olaparib in metastatic castration-resistant prostate cancer.
• (FDA) RET fusions associated with sensitivity to pralsetinib in non-small cell lung cancer.
• (FDA) RET somatic variants associated with sensitivity to selpercatinib in medullarly thyroid cancer.
• (FDA) RET fusions associated with sensitivity to selpercatinib in non-small cell lung cancer and thyroid cancer.
• (Inferential) COSMIC Signature 3, associated with Homologous Recombination Deficiency (HRD), associated with sensitivity to bevacizumab and olaparib in advanced ovarian, fallopian tube, and peritoneal cancer.

Edited entries:

• (Clinical trial) ATM frameshift, nonsense, and splice site somatic variants associated with sensitivity to BAY1895344 in any solid tumor. Updated disease context from "Advanced metastatic" to "Advanced or metastatic".