2024 December 5th release

This release contains 1,001 approved relationships.

Added entries:

• (FDA) KMT2A translocations and sensitivity to revumenib for adult and pediatric patients 1 year and older with acute leukemia, entered as acute myeloid leukemia and acute lymphoid leukemia.
• (FDA) NRG1 fusions and sensitivity to zenocutuzumab-zbco for adult patients with non-small cell lung cancer and pancreatic adenocarcinoma.

2024 November 7th release

This release contains 997 approved relationships.

Added entries:

• (FDA) BCR::ABL1 and sensitivity to asciminib for patients with chronic myeloid leukemia in chronic phase.
• (FDA) BCR::ABL1 and ABL1 p.T315I and sensitivity to asciminib for patients with chronic myeloid leukemia in chronic phase.
• (FDA) PIK3CA variants and sensitivity to inavolisib for patients with HR+, HER2-negative, locally advanced or metastatic breast cancer.

Revised entries:

• (FDA) BCR::ABL1 and sensitivity to asciminib for patients with previously treated chronic myeloid leukemia in chronic phase was generalized to be for previously treatmented patients, instead of specifically for previously treated with two or more TKIs.

2024 October 3rd release

This release contains 993 approved relationships.

Added entries:

• (FDA) EGFR p.L858R and exon 19 deletions and sensitivty to amivantamab-vmjw in combination with carboplatin and pemetrexed for the treatment of patients with non-small cell lung cancer.
• (FDA) EGFR p.L858R and exon 19 deletions and sensitivty to osimertinib for the treatment of patients with non-small cell lung cancer.

Revised entries:

• (FDA) RET somatic variants and sensitivity to selpercatinib for the treatment of patients with medullary thyroid cancer received an approval from the FDA, previously accelerated approval.
• (FDA) The description of three records corresponding to FDA approved indications for osimertinib were edited for clarity.
• (FDA) Six records for capivasertib in combination with fulvestrant incorrectly categorized fulvestrant as a targeted therapy. It has been updated to be a hormone therapy, and the therapy_type for each of these records has been updated to be "Combination therapy".
• (Clinical evidence) The PMID for Bostner et al. was incorrected listed as "7486065" instead of "17486065". The evidence category was also changed from Clinical evidence to Clinical trial. Thank you, Cameron Grisdale!

Four records listed therapy type either as "Targeted therapy + Chemotherapy", "Targeted therapy + Chemotherapy + Chemotherapy", or "Chemotherapy + Targeted therapy + Chemotherapy" instead of "Combination therapy". These records have been updated.

2024 September 5 release

This release contains 989 approved relationships.

Added entries:

• (FDA) IDH1 and IDH2 somatic variants and sensitivity to vorasidenib for patients with astrocytoma and oligodendroglioma. Specifically, IDH1 p.R132C, p.R132G, p.R132H, p.R132L, p.R132S, and IDH2 p.R172K and p.172G.
• (FDA) EGFR p.L858R and exon 19 deletions and sensitivity to lazertinib in combination with amivantamab for patients with non-small cell lung cancer.

2024 July 11 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.

2024 June 6 release

Added entries:

• (FDA) ALK fusions and sensitivity to alectinib for patients with non-small cell lung cancer.
• (FDA) BRAF p.V600E/K (p.V600 variants), rearrangements, and fusions and sensitivity to tovorafenib for patients with low-grade glioma.
• (FDA) EGFR p.L858R and exon 19 deletions and sensitivity to erlotinib for patients with non-small cell lung cancer.
• (FDA) EGFR p.L858R and exon 19 deletions and sensitivity to gefitinib for patients with non-small cell lung cancer.

Revised entries:

• (FDA) RET fusions and sensitivity to selpercatinib for patients with solid tumors is now indicated for pediatric patients aged 2 and older, in addition to adult patients.
• (FDA) RET fusions and sensitivity to selpercatinib for patients with thyroid cancer is now indicated for pediatric patients aged 2 and older, revised from age 12 or older.
• (FDA) RET variants and sensitivity to selpercatinib for patients with medullary thyroid cancer is now indicated for pediatric patients aged 2 and older, revised from age 12 or older.
• (FDA) RET fusion and sensitivity to selpercatinib for patients with non-small cell lung cancer's description and publication date were revised.

2024 April 11 release

Added entries:

• (FDA) ABL1 p.T315I and sensitivity to ponatinib for patients with acute lymphoid leukemia.
• (FDA) ABL1 p.T315I and sensitivity to ponatinib for patients with chronic myeloid leukemia.
• (FDA) BCR::ABL1 and sensitivity to ponatinib in combination with chemotherapy for patients with acute lymphoid leukemia.
• (FDA) BCR::ABL1 and sensitivity to ponatinib for patients with acute lymphoid leukemia.

Revised entries:

• The therapeutic strategy for two records with ROS inhibition were changed to ROS1 inhibition
• MRE11A somatic variants and sensitivity to enzalutamide in combination with talazoparib for patients with prostate cancer was updated to have the gene symbol be MRE11

All records were also updated to have a _deprecated field, which is a boolean value to hide the record from appearing on https://moalmanac.org.

2024 March 7 release

Added entries:

• (FDA) ALK fusions and sensitivity to crizotinib for patients with anaplastic large cell lymphoma.
• (FDA) EGFR exon 20 insertions and sensitivity to amivantamab-vmjw in combination with carboplatin and pemetrexed for patients with non-small cell lung cancer.
• (FDA) EGFR exon 19 deletions or p.L858R and sensitivity to osimertinib in combination with cisplatin and pemetrexed for patients with locally advanced or metastatic non-small cell lung cancer.
• (FDA) EGFR exon 19 deletions or p.L858R and sensitivity to osimertinib for patients with metastatic non-small cell lung cancer.
• (FDA) MET exon 14 splice site and deletion variants (exon 14 skipping) and sensitivity to tepotinib for patients with metastatic non-small cell lung cancer.

Revised entries:

• (FDA) ALK rearrangement and sensitivity to crizotinib, updated publication date from 2016-06-01 to 2011-08-26.
• (FDA) ALK fusion and sensitivity to crizotinib in patients with Inflammatory Myofibroblastic Tumors (IMT), removed EML4 as a required fusion partner and updated publication date from 2022-07-01 to 2022-07-14.
• (FDA) EGFR p.T790M and sensitivity to osimertinib, updated citation and publication date to reflect March 2017 approval (from accelerated approval) date for this indication.
• (FDA) EGFR exon 20 insertions and sensitivity to amivantamab-vmjw, updated publication date from 2021-05-01 to 2021-05-21.
• (FDA) EGFR exon 19 deletions or p.L858R and sensitivity to osimertinib as an adjuvant therapy for patients with metastatic non-small cell lung cancer, updated publication date from 2020-12-01 to 2020-12-11.
• (FDA) MET exon 14 splice site and deletion variants (exon 14 skipping) and sensitivity to capmatinib for patients with metastatic non-small cell lung cancer was updated to reflect the change from accelerated approval to approval in August 2022.
• (FDA) ROS1 fusions and sensitivity to crizotinib, updated publication date from 2016-06-01 to 2016-03-11.
• (Clinical trial) ATM nonsense, splice site, and frameshift variants and sensitivity to BAY 1895344 was revised to update its citation from an abstract (doi:10.1200/JCO.2019.37.15_suppl.3007) to the study's journal publication (pmid:32988960).
• (Clinical trial) MET amplification and sensitivity to crizotinib in patients with non-small cell lung cancer was revised to update its citation from an abstract (doi:10.1200/JCO.2018.36.15_suppl.9062) to the study's journal publication (pmid:33676017).

Removed entries:

• (FDA) MET exon 14 nonsense variants and sensitivity to capmatinib in patients with non-small cell lung cancer.
• (Guideline) MET exon 14 nonsense variants and sensitivity to crizotinib in patients with non-small cell lung cancer.

The U.S. FDA also granted accelerated approval to lifileucel for patients with unresectable or metastatic melanoma, but a drug label is not yet present for lifileucel. Our standard operating procedure was updated to no longer allow Abstracts as an evidence source for the knowledge base.

2024 February 1 release

Added entries:

• (FDA) BRAF p.V600E/K and sensitivity to vemurafenib for patients with Erdheim-Chester disease.

Revised entries:

• (FDA) BRCA1/2 somatic variants and sensitivity to rucaparib for patients with fallopean tube cancer had the oncotree term updated to High-Grade Serous Fallopian Tube Cancer.
• (FDA) FGFR3 fusions, p.R248C, p.S249C, p.G370C, and p.Y373C and sensitivity to erdafitinib for patients with urothelial carcinoma received an updated approval.
• "Oncogenic Mutations" was removed from the variant_annotation field from all 10 records with that value.

Removed entries:

• (FDA) FGFR2 fusions and sensitivity to erdafitinib for patients with urothelial carcinoma. The FDA amended their prior accelerated approval for erdafitinib, removing susceptible FGFR2 alterations from the indication.

2024 January 11 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.

The description or context within 14 records also received minor updates to improve clarity.

In addition, we updated our S.O.P. for curating clinical guidelines from the NCCN to reflect their referencing guide. All relevant records within this database were updated in our November 2023 release.