FDA approves talazoparib with enzalutamide for certain metastatic prostate cancers

The FDA approved talazoparib with enzalutamide on October 26, 2026, for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with homologous recombination repair (HRR) gene mutations. The mutations must be detected by an FDA-authorized test. The FDA previously approved FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostic devices for identifying eligible patients.

The approval was based on TALAPRO-3, a trial of 599 patients assigned to receive enzalutamide with either talazoparib or placebo. Median radiographic progression-free survival was not reached with talazoparib and enzalutamide, compared with 45.8 months with placebo and enzalutamide. At that analysis, overall survival data were immature. The prescribing information warns of myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity.