Pfizer Talzenna-Xtandi FDA Priority Review

Pfizer announced that the U.S. FDA has accepted for Priority Review a supplemental New Drug Application for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for the treatment of men with HRR gene-altered metastatic castration-sensitive prostate cancer (mCSPC). The FDA set a PDUFA action date in Q4 2026. The application is supported by Phase 3 TALAPRO-3 data showing a 52% reduction in risk of radiographic progression or death. The combination is already approved for metastatic castration-resistant prostate cancer (mCRPC) in the U.S. and over 60 countries. The European Union — European Medicines Agency is also reviewing the combination for mCSPC. If approved, the expanded label would allow earlier use in the disease course.