Health

FDA approves Talzenna plus Xtandi for earlier metastatic prostate cancer with HRR mutations

Washington, D.C. • October 26, 2026 • By Press Pass USA

Editorial illustration: a scientist in a laboratory holding a medicine bottle

Editorial illustration — Press Pass USA

The U.S. Food and Drug Administration on Monday approved talazoparib (Talzenna) in combination with enzalutamide (Xtandi) for adults with metastatic androgen pathway modulation-naive or -sensitive prostate cancer that harbors homologous recombination repair (HRR) gene mutations, as detected by an FDA-authorized test.

The decision moves the combination into an earlier stage of metastatic disease. The same pairing was previously approved in June 2023 for HRR-mutated metastatic castration-resistant prostate cancer, the more advanced, treatment-resistant form of the disease.

The approval rests on the phase 3 TALAPRO-3 trial, which enrolled 599 patients who had received three months or less of androgen deprivation therapy. Patients receiving talazoparib plus enzalutamide saw a 52% reduction in the risk of radiographic progression or death compared with enzalutamide plus placebo (hazard ratio 0.48), and an estimated 77% remained progression-free at three years. The benefit was consistent across BRCA and non-BRCA subgroups, according to Pfizer, and the results were presented at the 2026 American Society of Clinical Oncology annual meeting and published in The New England Journal of Medicine.

The FDA reviewed the application under Priority Review and Project Orbis, its framework for concurrent review with international partners. An application is also under review by the European Medicines Agency. Overall survival data were still immature at the time of the progression-free survival analysis, Pharmacy Times noted, so longer follow-up will be needed to confirm a survival benefit.

Sources: U.S. Food and Drug Administration (Oct 26, 2026); Pharmacy Times (Oct 26, 2026); Pfizer / BusinessWire (Oct 26, 2026).