The FDA approved talazoparib (Talzenna) in combination with enzalutamide for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer harboring HRR gene mutations. The decision relied on results from the randomized, double-blind, placebo-controlled TALAPRO-3 trial. Across 599 patients, talazoparib plus enzalutamide met the primary endpoint of radiographic progression-free survival, with median rPFS not reached versus 45.8 months for placebo plus enzalutamide and a hazard ratio of 0.48. Overall survival data were immature at the time of the rPFS analysis. The approval expands the treatment option set for newly diagnosed metastatic patients with HRR alterations, reinforcing PARP inhibition as a precision strategy beyond biomarker-stratified earlier settings.