The FDA said Wednesday it approved the drug, Xofigo from Bayer Pharmaceuticals, for men whose cancer has grown into bone tumors even after receiving medication or surgery to lower testosterone. The hormone spurs growth of prostate tumors.
More than 238,000 U.S. men will be diagnosed with prostate cancer this year and 29,720 will die from the disease, according to the National Cancer Institute.
Regulators approved Xofigo based on a study of 809 men with advanced prostate cancer who received the drug or placebo. Patients taking Xofigo typically lived 14 months compared to 11.2 months for those taking placebo.
Xofigo's side effects include nausea and diarrhea.
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