FDA Approves Talazoparib Plus Enzalutamide for Metastatic, HRR+ APMN/S Prostate Cancer

The FDA has approved talazoparib (Talzenna) in combination with enzalutamide (Erleada) for the treatment of adult patients with metastatic androgen pathway modulation–naive or –sensitive (mAPM/S) prostate cancer with homologous recombination repair (HRR) gene mutations, as detected by an FDA-authorized test.

The regulatory decision was backed by data from the phase 3 TALAPRO-3 trial (NCT04821622), in which talazoparib plus enzalutamide generated a statistically significant improvement in radiographic progression-free survival (rPFS) compared with placebo plus enzalutamide (HR, 0.48; 95% CI, 0.36-0.65; P < .0001). The median rPFS was not reached (NR; 95% CI, NR-NR) with the experimental combination vs 45.8 months (95% CI, 37.7-NR) with the placebo combination. Overall survival (OS) data were immature at the time of the PFS analysis.

In this indication, talazoparib is recommended at a dose of 0.5 mg orally once daily in combination with enzalutamide until disease progression or unacceptable toxicity.

References

1. FDA approves talazoparib with enzalutamide for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with HRR gene mutations. FDA. October 26, 2026. Accessed October 26, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-talazoparib-enzalutamide-metastatic-androgen-pathway-modulation-naive-or-sensitive