FDA Approves Talazoparib Combination for Metastatic Prostate Cancer with HRR Gene Mutations

The U.S. Food and Drug Administration (FDA) has approved talazoparib (Talzenna), a PARP inhibitor, in combination with enzalutamide (Xtandi) for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer that has homologous recombination repair (HRR) gene mutations. This decision was based on results from the Phase 3 TALAPRO-3 clinical trial, which showed a statistically significant improvement in radiographic progression-free survival with the combination therapy.