US pharma giant Pfizer (NYSE: PFE) on Thursday said a Phase III study combining its breast-cancer drug Talzenna (talazoparib), with its prostate-cancer drug Xtandi (enzalutamide) showed a 37% reduction in the risk of disease progression or death in men with metastatic castration-resistant prostate cancer (mCRPC).
Pfizer also noted that the US Food and Drug Administration (FDA) has granted Priority Review for Pfizer’s supplemental new drug application (sNDA) for Talzenna in combination with Xtandi for the treatment of men with mCRPC. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The FDA’s decision on the sNDA is expected in 2023.
Talzenna, a poly (ADP-ribose) polymerase (PARP) inhibitor, was approved by the FDA in 2018, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer.
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