FDA approves talazoparib plus enzalutamide in prostate cancer with HRR gene mutations

FDA,

FDAApproved

Talazoparib (Talzenna) + enzalutamide

Adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with HRR gene mutations, detected by an FDA-authorized test

The trial behind it

TALAPRO-3

0.48

Radiographic progression-free survival hazard ratio

95% CI 0.36–0.65; p<0.0001

NR

Median radiographic progression-free survival

Not reached, vs 45.8 months with enzalutamide + placebo

OncoAlert FDA News: talazoparib (Talzenna) plus enzalutamide approved by the US FDA for adults with mAPMN/S prostate cancer with HRR gene mutations, with key facts and efficacy from TALAPRO-3

Take-home

Talazoparib + enzalutamide now approved for mAPMN/S prostate cancer with HRR gene mutations. TALAPRO-3 delivered a clear rPFS benefit (HR 0.48).

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