The FDA has expanded approval of Pfizer’s Talzenna combined with Xtandi to treat men with metastatic hormone-sensitive prostate cancer carrying homologous recombination repair gene mutations, including BRCA and non-BRCA mutations.
The decision moves the combination into an earlier treatment setting. It was first approved in the United States in June 2023 for patients with HRR-mutated metastatic castration-resistant prostate cancer.
The expanded indication covers metastatic androgen pathway modulation-naïve or -sensitive disease, also known as metastatic hormone-sensitive prostate cancer.pfizer
Approval was supported by the Phase 3 TALAPRO-3 trial, which showed an estimated 52% reduction in the risk of radiographic disease progression or death. The FDA reviewed the application under Priority Review.
Talzenna, or talazoparib, is an oral PARP inhibitor that interferes with DNA damage repair. Xtandi, or enzalutamide, inhibits the androgen receptor pathway. Pfizer and Astellas jointly develop and commercialize Xtandi in the United States.
The FDA conducted its review through Project Orbis, which enables concurrent oncology drug submissions and reviews among participating international regulators. An application is under review by the European Medicines Agency, with other filings planned or underway.
The combination carries risks of bone marrow suppression. Grade 3 or higher anemia, neutropenia and thrombocytopenia were reported in 49%, 19% and 9% of patients receiving Talzenna with enzalutamide, respectively, according to the release’s safety information.
Talzenna also carries warnings for myelodysplastic syndrome and acute myeloid leukemia, including fatal cases. Its prescribing information calls for monthly blood count monitoring during treatment. Xtandi warnings include seizures, ischemic heart disease, falls and fractures.
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