India, July 22 -- Pfizer Inc. (PFE) said the U.S. FDA has accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA (talazoparib), in combination with XTANDI (enzalutamide) for men with metastatic castration-sensitive prostate cancer (mCSPC), carrying homologous recombinant repair (HRR) gene alterations. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the last quarter of 2026.
TALZENNA plus XTANDI is already approved in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The new filing seeks to expand use of the regimen to patients earlier in the disease course.
The submission is backed by data from the Phase 3 TALAPRO-3 study, which showed the combinati...