The U.S. Food and Drug Administration (FDA) expanded approval for Pfizer’s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) to treat patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) gene mutations. The approval allows the combination to be used at an earlier stage of the disease.
In the Phase 3 TALAPRO-3 trial, the combination reduced the risk of disease progression or death by 52% compared with Xtandi alone.
The combination was first approved in 2023 for a later form of prostate cancer.