Decision about enzalutamide in chemo-naive mCRPC

According to a joint media release, issued yesterday by Medivation and Astellas, the U.S. Food & Drug Administration (FDA) has granted a priority review for the supplementary New Drug Application (sNDA) for the use of enzalutamide in the treatment of chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC).

This priority review means that the FDA will make a decision on or before September 18, 2014 — based on data from the PREVAIL trial — regarding approval of the use of enzalutamide in patients with chemotherapy-naive mCRPC. The “New” Prostate Cancer InfoLink expects this decision to be favorable for the companies (and for patients), and it may well come significantly earlier than mid-September.

One Response

  1. Good. We need it approved.

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