FDA approved talazoparib plus enzalutamide for adults with metastatic hormone-sensitive prostate cancer harboring homologous recombination repair (HRR) gene mutations, using data from the randomized, double-blind, placebo-controlled TALAPRO-3 trial. The phase 3 study enrolled 599 patients and reported a statistically significant improvement in radiographic progression-free survival (rPFS), the primary endpoint. The combination did not reach median rPFS versus 45.8 months for placebo plus enzalutamide, with a hazard ratio of 0.48 (P<.0001). Overall survival data were immature at the time of analysis. The approval covers a range of HRR alterations identified prospectively through tumor tissue or circulating tumor DNA next-generation sequencing, including BRCA1, BRCA2, ATM and others. The regulator’s decision adds another PARP inhibitor–based regimen to the HRR-mutated prostate cancer treatment landscape.