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FDA Approves Radium Drug Xofigo for Metastatic Prostate Cancer

Drug delivers radiation directly to bone tumors (May 15)

The FDA has approved Xofigo (radium Ra 223 dichloride; Bayer Pharmaceuticals) for the treatment of men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone levels.

According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013. Testosterone stimulates prostate tumors to grow.

Xofigo (radium Ra 223 dichloride) was approved more than 3 months ahead of the product’s prescription drug user fee goal date of August 14, 2013.

The drug binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues.

Xofigo is the second prostate cancer drug approved by the FDA within the past year. In August 2012, the agency approved Xtandi (enzalutamide; Astellas Pharma U.S./Medivation, Inc.) for the treatment of men with metastatic castration-resistant prostate cancer that had spread or recurred, even with medical or surgical therapy to minimize testosterone. Xtandi was approved for patients who had been treated with the chemotherapy drug docetaxel.

The safety and effectiveness of Xofigo were evaluated in a single clinical trial involving 809 men with symptomatic castration-resistant prostate cancer that had spread to bones but not to other organs. The patients were randomly assigned to receive Xofigo or placebo plus best standard of care. The study was designed to measure overall survival.

Results from an interim analysis showed that men receiving Xofigo lived a median of 14.0 months compared with a median of 11.2 months for men receiving placebo. An updated analysis conducted later in the trial confirmed the ability of Xofigo to extend overall survival.

The most common side effects reported during clinical studies in men receiving Xofigo included nausea, diarrhea, vomiting, and swelling of the leg, ankle, or foot.

Source: FDA; May 15, 2013.

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