FDA grants priority review to talazoparib plus enzalutamide for HRR gene-altered mCSPC

The FDA granted priority review to Pfizer's talazoparib plus enzalutamide for metastatic castration-sensitive prostate cancer with HRR gene alterations, with PDUFA target action in Q4 2026. The phase 3 TALAPRO-3 trial showed a 52% reduction in radiographic progression or death versus enzalutamide alone, with stronger efficacy in BRCA-mutated patients (63% risk reduction).

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