The FDA approved talazoparib (Talzenna) plus 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 TALAPRO-3, a randomized, double-blind, placebo-controlled Phase 3 trial that enrolled 599 patients. In the primary analysis, median radiographic progression-free survival (rPFS) was not reached in the talazoparib arm versus 45.8 months with placebo (HR 0.48; P<.0001). Overall survival data were immature at the time of the rPFS cut, but the benefit was reported as consistent across BRCA and non-BRCA HRR mutations. The decision expands the treatment options for newly diagnosed metastatic HRR-mutated disease, where existing choices are limited and resistance can emerge early during androgen-axis therapy.