The FDA has approved Pfizer’s talazoparib (Talzenna) in combination with enzalutamide for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with homologous recombination repair gene mutations.
The approval was based on the TALAPRO-3 trial of 599 patients, according to an Oct. 26 FDA notice. Patients were randomized 1:1 to receive enzalutamide plus either talazoparib or placebo daily. All patients also received continuous androgen deprivation therapy.
Median radiographic progression-free survival was not reached among patients receiving talazoparib and enzalutamide, compared with 45.8 months among those receiving placebo and enzalutamide. Overall survival data were immature at the time of the analysis.
The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression and embryo-fetal toxicity. The recommended talazoparib dose is 0.5 milligrams orally once daily with enzalutamide until disease progression or unacceptable toxicity.
The application was granted priority review.
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