According to a media release issued late yesterday by Medivation and Astellas Pharma, Medivation has just submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval to market enzalutamide (a.k.a MDV3100).
The companies have previously reported data on the effectiveness and safety of enzalutamide in the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) who have received at least one cycle of treatment with docetaxel-based chemotherapy.
If the FDA carries out a rapid review of the enzalutamide application, and if there are no significant issues related to the application, it is still reasonable to expect that enzalutamide might be approved before the end of 2012.
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Search for new and
ongoing trials on the
CTAG PCa web site
In a related development Medivation (or someone) has removed the recruiting site for the pre-chemo trial of enzalutimide. It was /how-mdv3100-works.html, but that leads to a “404 not found” message. The company still has a link to that site on a company page but it also leads to the same message. Unless there has been a serious error in technology, I conclude the recruitment is complete.
Dear Tarhoosier:
I think this is a technology issue on the Medivation web site. If you look at the ClinicalTrials.gov web site, the information is clear that enrollment is still open for the PREVAIL trial of enzalutimide in chemotherapy-naive patients.