The FDA approved an earlier combination for some metastatic prostate cancers

On October 26, 2026, the Food and Drug Administration approved talazoparib, sold as Talzenna, together with enzalutamide for adults with metastatic prostate cancer that is still sensitive to hormone treatment and that carries a homologous recombination repair gene mutation, Healio reported. A 2023 approval covered a later setting, after the cancer had stopped responding to that kind of treatment. The new decision lets eligible men start the combination sooner. The lead investigator, Neeraj Agarwal, is a medical oncologist at Dana-Farber Cancer Institute in Boston.

The evidence is the phase 3 TALAPRO-3 trial. It enrolled 599 men and assigned them at random to daily talazoparib plus enzalutamide or to a placebo plus enzalutamide. The combination lowered the risk of the cancer growing on scans, or of death, by 52% compared with enzalutamide alone. Median time to that radiographic worsening was not yet reached in the combination group and was 45.8 months in the comparison group. Overall survival numbers were not mature when regulators looked at the scans, so the approval does not rest on a finished survival comparison. Anemia was the most common severe side effect the manufacturer reported.