Pfizer gets USFDA priority review for prostate cancer drug Xtandi
XTANDI (enzalutamide) is an androgen receptor signaling inhibitor.;
New York: Pfizer Inc. and Astellas Pharma Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the companies’ supplemental New Drug Application (sNDA) for XTANDI (enzalutamide) for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC; also known as non-metastatic hormone-sensitive prostate cancer or nmHSPC) with high-risk biochemical recurrence (BCR).
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 Prescription Drug User Fee Act (PDUFA) date for an anticipated FDA decision is in Q4 2023.
“The FDA’s granting of a Priority Review designation reinforces the need to bring new treatment options for patients with high-risk biochemical recurrent nmCSPC,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Research and Development Officer, Executive Vice President, Pfizer. “We believe the EMBARK data demonstrate the potential of XTANDI, if approved, to help patients earlier in the course of their disease, building on XTANDI’s foundation as an existing standard of care in prostate cancer.”
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