Priority review to Pfizer’s TALZENNA plus XTANDI combination for metastatic prostate cancer

Pfizer has recently announced that the US FDA has accepted for Priority Review a supplemental New Drug Application for TALZENNA, an oral poly ADP-ribose polymerase inhibitor, combined with XTANDI, an androgen receptor pathway inhibitor, in men with homologous recombination repair gene-altered metastatic castration-sensitive prostate cancer, also referred to as metastatic hormone-sensitive prostate cancer.

TALZENNA plus XTANDI already holds approval in the US for men with HRR gene-mutated metastatic castration-resistant prostate cancer. A successful outcome for the supplemental application would extend the combination’s reach to metastatic castration-sensitive prostate cancer, an earlier point in the disease course.

“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,” said Jeff Legos, Chief Oncology Officer, Pfizer. “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.”

Evidence from the Phase 3 TALAPRO-3 trial underpins the submission, with the study showing that TALZENNA plus XTANDI reduced the risk of radiographic progression or death by 52% against placebo plus XTANDI. The benefit was consistent across patients carrying both BRCA and non-BRCA HRR gene alterations, and the safety profile aligned with what is already established for each agent individually, with no new concerns identified. These findings were presented at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine.

---

---

Related Topics and Keywords

metastatic prostate cancer, Pfizer, prostate cancer, talzenna, XTANDI®