FDA Clears Combination Therapy for Metastatic HRR-Mutated Prostate Cancer

The U.S. FDA has approved talazoparib (Talzenna) combined with enzalutamide (Erleada) for adult patients with metastatic androgen pathway modulation–naive or –sensitive prostate cancer featuring homologous recombination repair (HRR) gene mutations. This regulatory decision is supported by data from the Phase 3 TALAPRO-3 trial. The trial demonstrated a statistically significant improvement in radiographic progression-free survival for patients receiving the combination therapy compared to placebo plus enzalutamide.