Approvals Brief October 26, 2026, 2:01 PM ET

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.

Primary source

FDA approval notification, October 26, 2026

FDA approves talazoparib with enzalutamide for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with HRR gene mutations

Read the source: FDA approves talazoparib with enzalutamide for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with HRR gene mutations fda.gov

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