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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).