Radium-223 Granted Priority Review by FDA

March 2013, Vol 4, No 3 - FDA Approvals, News & Updates


The FDA has granted priority review to radium-223 (radium-223) dichloride (Bayer), formerly known as Alpharadin, for the treatment of patients with prostate cancer. The New Drug Application for radium-223 is being reviewed for the treatment of patients with castration-resistant prostate cancer (CRPC) with bone metastases. This designation supports the manufacturer’s “ongoing effort to make this compound available as early as possible for patients in need of new treatment options,” said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

Radium-223 is a therapeutic alpha particle–emitting pharmaceutical with targeted antitumor effect on bone metastases that has been developed for patients with CRPC and bone metastases. The application is based on results from the pivotal phase 3 ALSYMPCA trial, in which radium-223 plus best standard of care significantly increased OS by 44% compared with placebo plus best standard of care (P = .007), resulting in a 30.5% mortality risk reduction. (February 13, 2013)