View on GitHub

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.