FDA approves enzalutamide for treatment of post-chemotherapy ...

Posted on August 31, 2012 by Sitemaster

Demonstrating (once again) that the U.S. Food and Drug Administration (FDA) moves with alacrity when presented with good data to support the approval of important new therapeutic agents, the agency has today approved enzalutamide (to be known as Xtandi^?) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel-based chemotherapy.

A media release issued jointly by Medivation and Astellas Pharma provides additional information about this approval.

Full prescribing information for enzalutamide can be found on the FDA web site.

The ?New? Prostate Cancer InfoLink admits that we were not expecting an approval of enzalutamide this quickly, which has to be a testament to both the quality of the New Drug Application (NDA) submitted by the drug?s developers, as well as the commitment of the FDA to turn good applications around on a highly accelerated schedule.

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Filed under: Drugs in development, Management, Treatment Tagged: | enzalutamide, MDV3100

Source: http://prostatecancerinfolink.net/2012/08/31/fda-approves-enzalutamide-for-treatment-of-post-chemotherapy-mcrpc/

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