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 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.