WASHINGTON — The Food and Drug Administration said Friday it approved the pill Xtandi for men with advanced prostate cancer that has returned or spread despite major medical intervention.
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The drug, developed by Medivation, is indicated for patients who have already tried the chemotherapy drug docetaxel and testosterone-limiting interventions. Doctors use drugs or surgery to limit testosterone, which can spur growth of prostate tumors.
More than 241,000 men will be diagnosed with prostate cancer this year and 28,170 will die from the disease, according to an estimate by the National Cancer Institute.
Regulators approved Xtandi based on a study of 1,200 patients with advanced prostate cancer who received the drug or a placebo. Patients taking Xtandi survived 18.4 months after beginning treatment, or nearly 5 months longer than patients taking placebo, who survived 13.6 months, on average.
The most common side effects seen with the drug include fatigue, back pain, diarrhea, headache and dizziness.
Xtandi was developed by San Francisco-based Medivation with financial and research support for Japanese drugmaker Astellas Pharmaceuticals. The companies will share the marketing costs and profits from the drug.
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