The Priority Review

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enzalutamide

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  1. Approvals

    FDA approves talazoparib with enzalutamide for metastatic prostate cancer

    On October 26, 2026, the FDA approved talazoparib (Talzenna, Pfizer Inc.) in combination with enzalutamide for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with homologous recombination repair gene mutations, as detected by an FDA-authorized test. The TALAPRO-3 trial showed median radiographic progression-free survival not reached (95% CI: NR, NR) versus 45.8 months (95% CI: 37.7, NR) with a hazard ratio of 0.48 [95% CI: 0.36, 0.65]; p<0.0001.