Drug Makers Seek New Indication for Prostate Cancer Drug

Astellus Pharma and Medivation ask the FDA to approve enzalutamide as a treatment for advanced PCa.
Astellus Pharma and Medivation ask the FDA to approve enzalutamide as a treatment for advanced PCa.

Astellus Pharma Inc. and Medivation Inc., have submitted a supplemental New Drug Application for enzalutamide (XTANDI) in the treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who have not received chemotherapy, according to a press release by the manufacturers.

The drug is currently approved for treatment only in patients who have previously received docetaxel chemotherapy. As part of the phase 3 PREVAIL trial that enlisted more than 1,700 patients from around the world, enzalutamide demonstrated a 30% reduction in risk of death as well as an 81% reduction in radiographic progression risk compared with placebo.

By interim analysis, 72% of patients were alive in the enzalutamide arm compared with 65% among placebo recipients.

Enzalutamide is a novel, once-daily oral drug that blocks androgen from binding to androgen receptors.

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