Pfizer's Talzenna-xtandi Combo Gets FDA Priority Review for Earlier-stage Prostate Cancer

Dow Jones07-23 05:26

Pfizer said Wednesday the Food and Drug Administration accepted for priority review its supplemental application seeking to expand the use of its prostate cancer treatment Talzenna in combination with Xtandi to patients with an earlier stage of advanced disease.

The drugmaker said the supplemental new drug application seeks approval for the combination in men with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer, also known as metastatic hormone-sensitive prostate cancer. The FDA set a decision date in the fourth quarter of 2026.

Talzenna plus Xtandi is already approved in the U.S. to treat men with HRR gene-mutated metastatic castration-resistant prostate cancer. If approved, the expanded label would allow the therapy to be used earlier in the course of the disease.

The filing is supported by data from the Phase 3 TALAPRO-3 trial, which showed the combination reduced the risk of radiographic disease progression or death by 52% compared with Xtandi alone. Pfizer said the benefit was consistent across patients with both BRCA and non-BRCA HRR gene alterations, with no new safety signals identified.

The application is also under review by the European Medicines Agency.

Write to Anvee Bhutani at anvee.bhutani@wsj.com

(END) Dow Jones Newswires

July 22, 2026 17:26 ET (21:26 GMT)

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