Pfizer Inc. announced an update on June 13, 2025, regarding the U.S. Food and Drug Administration's (FDA) review of their supplemental New Drug Application (sNDA) for TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide) for treating metastatic castration-resistant prostate cancer (mCRPC). The FDA has approved updated labeling to include final overall survival data for treating adults with homologous recombination repair $(HRR.AU)$ gene-mutated mCRPC. However, the FDA did not grant approval to expand the indication to patients with non-HRR gene mutated mCRPC, citing insufficient evidence for a favorable benefit-risk profile in this subgroup from the Phase 3 TALAPRO-2 trial. Consequently, Pfizer will not pursue an expanded indication for this combination in mCRPC within the United States.
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