FDA grants priority review to oncology drug radium-223 dichloride

FDA has granted priority review to oncology compound radium-223 dichloride (radium-223, Bayer HealthCare) for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases.

Radium-223 dichloride (radium-223), formerly referred to as Alpharadin, is a therapeutic alpha particle-emitting pharmaceutical with targeted anti-tumor effect on bone metastases in development for CRPC patients with bone metastases.

“FDA’s approval of the priority review of [radium-223 dichloride] for prostate cancer can be viewed as another groundbreaking move by FDA to increase the number of treatment options that will be available for this type of cancer,” said Formulary Advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, in Webster, Texas. “The priority review status of radium-223 dichloride may be indicative of its favorable status in the eyes of FDA and the potential for its subsequent approval, but only time will confirm this.”

The submission was based on data from the pivotal phase 3 ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. In the study, radium-223 significantly increased overall survival by 44% (HR=0.695, P=.00007), resulting in a 30.5% reduction in the risk of death compared to placebo. The median overall survival (OS) benefit in patients with radium-223 was 3.6 months, based on 14.9 months OS with radium-223 plus best standard of care (BSoC) versus 11.3 months with placebo plus BSoC. These updated results were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012.