Overview
- The US Food and Drug Administration has accepted Pfizer’s supplemental new drug application for Priority Review and set a PDUFA action date in the fourth quarter of 2026.
- The filing seeks to expand use of talazoparib (Talzenna) plus enzalutamide (Xtandi) from metastatic castration-resistant disease to homologous recombination repair (HRR) gene‑altered metastatic castration‑sensitive prostate cancer, an earlier disease stage.
- The application rests on phase 3 TALAPRO-3 results showing a 52% lower risk of radiographic progression or death versus placebo plus enzalutamide, with no new safety signals reported and the data published in The New England Journal of Medicine.
- Biomarker testing will be central to patient selection because about 5–10% of new prostate cancers present as mCSPC and up to roughly 30% of those cases may carry HRR gene alterations that the regimen targets.
- Regulators in Europe are reviewing the same indication, the combination is already approved for HRR‑mutated mCRPC in more than 60 countries, and approval could increase early testing and shift treatment practice toward earlier combination therapy.