Pfizer Inc (NYSE:PFE) and Astellas Pharma Inc. reported that a supplemental New Drug Application for XTANDI® has been accepted for submission and allowed Priority Review designation by the U.S. FDA. If permitted, the sNDA would grow the indication of XTANDI to comprise men with non-metastatic CRPC, based on report from the Phase III PROSPER study. XTANDI is currently meant for the treatment of people with metastatic CRPC.
The FDA gives Priority Review designation to filings for drugs that, if permitted, may offer considerable improvements in the effectiveness and safety of the treatment of grave conditions as compared to standard applications. Pfizer reported that under priority review, the FDA intends to take action on a filed application within 6 months of receipt, as against 10 months under standard review.
The PDUFA goal date given by the FDA is of this July. In addition, the EMA has validated the Type 2 Variation submitted for XTANDI looking to expand the existing indication to the same patient group and commenced the review procedure on March 5. Steven Benner, M.D., expressed that once cancer grows and metastasizes, males with castration-resistant prostate cancer experience a scary prognosis and challenging odds. They are delighted to see the Priority Review designation as they work to potentially offer XTANDI to males struggling with non-metastatic CRPC.
Mace Rothenberg, M.D., of Pfizer Global Product Development, expressed that treatment alternatives have been limited for males with non-metastatic CRPC, in whom the mere evidence of progressive ailment is a rapidly rising PSA. XTANDI is already recognized as a standard of care for males with metastatic CRPC. This achievement marks a vital step toward their ability to offer XTANDI to CRPC patients in a prior setting. The PROSPER study assessed XTANDI plus ADT versus ADT alone in around 1,400 subjects with non-metastatic CRPC.
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