FDA grants priority review to metastatic PCa agent

February 19, 2013

The FDA has granted priority review to the new drug application filed for radium-223 dichloride, an investigational compound under review for the treatment of patients with castration-resistant prostate cancer who have bone metastases.

The FDA has granted priority review to the new drug application filed for radium-223 dichloride, an investigational compound under review for the treatment of patients with castration-resistant prostate cancer who have bone metastases.

The submission was based on data from the pivotal phase III 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.

The FDA grants priority review to medicines that offer major advances in care or that provide a treatment where no adequate therapy exists. Under the Prescription Drug User Fee Act, the FDA aims to complete its review within 8 months from the submission of the new drug application, rather than the standard 12-month review cycle.

The application for radium-223 was filed in December 2012.