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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).