On May 15th, 2013, the U.S. Food and Drug Administration approved Xofigo (previously known as Alpharadin) for use in men with treatment-resistant prostate cancer that had metastasized to bones but not to other organs. Xofigo, administered by injection, will be marketed by Bayer Healthcare Pharmaceuticals who developed the therapy jointly with Algeta, ASA, a Norwegian pharmaceutical company. The drug works by delivering radioactive alpha particles directly to prostate cancer cells that have formed tumors in bone. The radioactive alpha particles from radium-223 dichloride are relatively “heavy” and therefore do not penetrate very far in the body thus limiting the effect of the drug to about a 10-cell radius thereby limiting its toxicity. The drug binds with minerals in the bone to deliver radiation directly to the bones limiting damage to surrounding tissues. In Phase III clinical trials, men given Xofigo experienced a six-month longer timeframe to first complications (fractures or spinal cord compression) occurring as a result of bone tumors, a survival advantage of about 3 months and a higher quality of life. Xofigo also produced a 50% reduction in the risk of spinal cord compression caused by tumors—a complication that can result in paralysis, severe pain, and other loss of functions.
Further information was reported in the May 31st, 2013 issue of the Prostate Cancer Foundation NewsPulse, and a special May 15th bulletin from the Prostate Cancer Research Institute (PCRI). Additional information including a video from Duke University describing the potential role of Xofigo in the overall sequence of prostate cancer treatment was published in the June 28th, 2013 issue of the PCF NewsPulse. Patients who are interested in finding out where and when Xofigo will be available can call 1-855-696-3446 (1-855-6Xofigo) or visit the website http://xofigo-us.com/index.php.