TALZENNA (talazoparib) + XTANDI (enzalutamide) - (TALAPRO-3)

July 22, 2026: Pfizer Inc. (NYSE: PFE) announced the FDA accepted for Priority Review a supplemental NDA for TALZENNA (talazoparib) plus XTANDI (enzalutamide) in men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC/mHSPC). The FDA set a PDUFA action date in the last quarter of 2026. The combination is already indicated in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC); approval would expand use to an earlier disease stage.

The filing is supported by the Phase 3 TALAPRO-3 trial (NCT04821622; n=599), where talazoparib + enzalutamide reduced risk of radiographic progression or death by 52% versus placebo + enzalutamide, with consistent benefit across BRCA and non-BRCA HRR alterations and no new safety signals. Results were presented at the 2026 ASCO Annual Meeting and published in The New England Journal of Medicine. The mCSPC use is also under review by the European Medicines Agency.