FDA approves talazoparib plus enzalutamide for a new prostate cancer population
The approval covers metastatic prostate cancer patients with HRR gene mutations who have not yet received or are still responding to androgen pathway modulation.
The Food and Drug Administration approved talazoparib, sold as Talzenna by Pfizer Inc., in combination with enzalutamide on October 26, 2026. The approval covers adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with HRR gene mutations.1
The FDA's notice does not provide further detail on trial data, dosing, or efficacy results beyond the approval announcement itself. Readers seeking additional information on the clinical basis for the approval should consult the full FDA record.
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