This combination targets men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer.
The FDA has set the Prescription Drug User Fee Act (PDUFA) action date for the last quarter of 2026.
Stay ahead of biotech and pharmaceutical market-moving events with the CatalystPICR FDA Calendar.
The application is backed by data from the Phase 3 TALAPRO-3 trial, which demonstrated that the combination of TALZENNA and XTANDI reduced the risk of radiographic progression or death by 52 percent compared to placebo plus XTANDI.
The trial showed consistent benefits across patients with both BRCA and non-BRCA HRR gene alterations, maintaining a safety profile in line with known profiles of each agent without new safety signals.
Currently, TALZENNA plus XTANDI is approved in the U.S. for men with HRR gene-mutated metastatic castration-resistant prostate cancer.
The potential approval of this combination for a broader patient population could provide a new treatment option aimed at delaying disease progression during the hormone-sensitive stage of prostate cancer.
Jeff Legos, Chief Oncology Officer, Pfizer, commented, “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,” he added.
