New drug approved for late-stage prostate cancer [The Oregonian, Portland, Ore.]

Aug. 31--The Food and Drug Administration has approved a new drug for late-stage prostate cancer, Xtandi. It is taken orally and targets castration-resistant prostate cancer that has spread or recurred.

About 241,000 men will be diagnosed with prostate cancer in 2012, and 28,000 will die from it.

Approval followed a study of 1,199 patients with metastatic cancer who had previously been treated with docetaxel. Men treated with Xtandi lived an average of 18.4 months, nearly five months longer than those who received a sugar-pill placebo.

Knight Cancer Institute researchers at Oregon Health & Science University helped evaluate the drug.

"For the prostate cancer community and for the Knight this is a really big deal," said Dr. Tomasz Beer, deputy director of OHSU Knight Cancer Institute.

According to the FDA, the most common side effects include fatigue, weakness, diarrhea, joint or back pain, hot flush, headache, spinal cord compression, diffiulty sleeping, blood in urine, anxiety and respiratory infections. Seizures occurred in about 1 percent of patients. Safety has not been evaluated for patients with a history of seizure, brain injury, stroke or certain other conditions.

The drug will be marketed by the San Francisco firm Medivation, Inc. and the U.S. subsidiary of the Japanese firm Astellas Pharma.

-- Nick Budnick

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