FDA Approves Talzenna for Earlier-Line Metastatic Prostate Cancer with HRR Gene Mutations

The U.S. Food and Drug Administration (FDA) has approved Talzenna (talazoparib) in combination with enzalutamide for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (mHSPC) who have homologous recombination repair (HRR) gene mutations. This approval moves the PARP inhibitor combination into an earlier disease setting, based on results from the Phase 3 TALAPRO-3 trial which showed a 52% reduction in the risk of radiographic progression or death.