The FDA approved talazoparib (Talzenna) in combination with enzalutamide (Xtandi) for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer carrying homologous recombination repair (HRR) gene mutations. The approval is based on the randomized, double-blind, placebo-controlled TALAPRO-3 trial. In the Phase 3 study of 599 patients, the combination significantly improved the primary endpoint, investigator-assessed radiographic progression-free survival. Median rPFS was not reached with talazoparib plus enzalutamide versus 45.8 months with placebo plus enzalutamide, with a hazard ratio of 0.48. Overall survival data were immature at the time of the rPFS analysis, and regulators said benefits appeared consistent across both BRCA and non-BRCA HRR mutations.