FDA Approves Expanded Use of Talzenna and Xtandi for Specific Prostate Cancer

The FDA has expanded approval for Talzenna (talazoparib) combined with Xtandi (enzalutamide) to treat adult men with metastatic hormone-sensitive prostate cancer featuring homologous recombination repair (HRR) gene mutations. This decision, based on Phase 3 TALAPRO-3 trial results, allows the regimen to be used earlier in treatment, contingent on an FDA-authorized biomarker test. This offers a new option for a specific patient population.