Thursday, May 16, 2013 (Last Updated: 05/17/2013)THURSDAY, May 16 (HealthDay News) -- The U.S. Food and Drug Administration has approved a drug to help men with advanced prostate cancer whose disease has spread to the bones.
The drug, Xofigo (radium Ra 223 dichloride), is targeted to patients with late-stage, metastatic disease that has spread to the bones but not to other organs, the FDA said in a news release. It is meant for patients who have already undergone surgery and/or drug therapies such as hormone-based treatments.
In a clinical trial involving more than 800 men with symptomatic prostate cancer that was resistant to hormonal therapy and had spread to the bones, men on Xofigo survived a median of 14 months compared to a little over 11 months for men taking a placebo. Side effects from Xofigo included nausea, diarrhea, vomiting, and swelling of the legs and feet. Low levels of red and white blood cells, as well as platelets, were also reported among some patients taking Xofigo, the FDA said.
According to the American Cancer Society, prostate cancer remains the leading cancer type among men outside of skin cancer, and about one man in every six will develop the illness during his lifetime. Caught early, it is often curable. About 239,000 new cases of prostate cancer are diagnosed among American men each year, and nearly 30,000 men die from the disease annually.
Xofigo is co-marketed in the United States by Wayne, N.J.-based Bayer Pharmaceuticals and Algeta, of Cambridge, Mass.
Hematology & Oncology