According to a joint media release issued by Medivation and Astellas Pharma, the US Food & Drug Adminstration (FDA) has informed Medivation that the Prescription Drug User Fee Act (PDUFA) action date for the review of the new drug application (NDA) for enzalutamide (also known as MDV3100) will be November 22, 2012.
To all intents and purposes, this means that the FDA will decide on or before November 22 whether to approve this NDA for the use of enzalutamide in the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) previously treated with docetaxel-based chemotherapy.
Technically, please understand that the FDA has several options available:
- It can simply approve the application for use of enzalutamide in treatment of men with mCRPC who have received one or more cycles of treatment with docetaxel-based chemotherapy.
- It can reject the application
- It can advise the applicant (Medivation) that it needs additional data before coming to a final decision.
It seems highly likely to The “New” Prostate Cancer InfoLink that the FDA will indeed approve enzalutamide, but counting chickens bewfore they are hatched is a dangerous game, so don’t tell us you haven’t been warned.