FDA Approves Pfizer's Talazoparib-Enzalutamide Combo for Prostate Cancer

The FDA approved Pfizer's talazoparib (Talzenna) in combination with enzalutamide for adults with metastatic prostate cancer carrying homologous recombination repair gene mutations, according to an Oct. 26 FDA notice. The approval relied on the TALAPRO-3 trial of 599 patients, which found median radiographic progression-free survival was not reached in the talazoparib-enzalutamide arm versus 45.8 months with placebo-enzalutamide; overall survival data remain immature. The drug carries warnings for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression and embryo-fetal toxicity, and is dosed at 0.5 mg orally once daily until disease progression or unacceptable toxicity. The application received priority review.

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