Xtandi Approved for Advanced Prostate Cancer

FRIDAY Aug. 31, 2012 -- Xtandi (enzalutamide) has been approved to treat men with prostate cancer that has spread despite treatment with standard therapies aimed at minimizing the effects of testosterone.

Testosterone stimulates prostate tumors to grow, the FDA explained Friday in a news release. Xtandi has been approved for prostate cancer patients previously treated with another anti-cancer drug, docetaxel.

The U.S. National Cancer Institute estimates that almost 242,000 men will be diagnosed with prostate cancer this year, and more than 28,000 will die from it.

Xtandi, given priority FDA review, was evaluated in clinical studies of almost 1,200 men with metastatic, hormone treatment-resistant prostate cancer who had taken docetaxel previously. Average survival among those who took Xtandi was 18.4 months, compared with 13.6 months among those who took a placebo.

Seizures occurred in about 1 percent of clinical participants who took Xtandi. The study excluded men with conditions including a history of seizure, stroke or a brain injury that involved loss of consciousness, the FDA said.

The most common side effects of the drug included fatigue, back pain, diarrhea, joint pain, hot flushes, tissue swelling, musculoskeletal pain and headache.

Xtandi is co-marketed by Northbrook, Ill.-based Astellas Pharma U.S., and San Francisco-based Medivation Inc.

More information

The U.S. National Cancer Institute has more about prostate cancer.

Posted: August 2012


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