FDA Grants Priority Review to TALZENNA Plus XTANDI for HRR – Altered Metastatic Castration – Sensitive Prostate Cancer – Pfizer
Pfizer announced that the FDA accepted for Priority Review a supplemental New Drug Application (sNDA) for Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the last quarter of 2026.
Talzenna plus Xtandi is currently indicated in the U.S. for men with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). If approved, the sNDA would expand the combination’s use to mCSPC, an earlier stage of disease.
“For men living with metastatic prostate cancer, intervening during the hormone-sensitive stage represents an important opportunity to delay progression before the disease becomes more difficult to manage. If approved, Talzenna plus Xtandi would offer patients with HRR-driven disease a new treatment option that could help them live longer without their cancer progressing. The data supporting this application also reinforce the importance of biomarker testing to inform treatment decisions as early as possible.” – Jeff Legos, Chief Oncology Officer, Pfizer.
The application is supported by data from the Phase 3 TALAPRO-3 trial (NCT04821622) which showed Talzenna plus Xtandi reduced the risk of radiographic progression or death by 52% versus placebo plus Xtandi, with consistent benefit across patients with BRCA and non-BRCA HRR gene alterations, and a safety profile consistent with the known profiles of each agent and no new safety signals. These results were presented at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published in TheNew England Journal of Medicine.
The use of Talzenna plus Xtandi in HRR gene-mutated mCSPC is also under review by the European Medicines Agency. Talzenna plus Xtandi is currently approved for mCRPC in more than 60 countries, with specific indications varying by country.
