FDA grants priority review for MDV3100 in mCRPC

According to a media release issued by Medivation, the U.S. Food and Drug Administration has accepted and granted priority review of the company’s new drug application for enzalutamide (a.k.a. MDV3100) as a treatment for men with metastatic, castration-resistant prostate cancer (mCRPC).

2 Responses

  1. What , exactly, does “priority review” mean? Any hint of when the drug
    will be available to the public?

  2. “Priority review” is a formal process requiring the FDA to complete their review of the application within a rapid and defined timeframe. The goal for completing a Priority Review is 6 months from receipt of the completed application (which occurred at the end of May this year). We can therefore expect an FDA decision about enzalutamide before the end of this year — and opinions seem to range from September through to November.

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