BayerHealthCare submits Alpharadin to FDA for treatment of castration-resistant Prostate Cancer

Bayer HealthCare has submitted a New Drug Application to the FDA seeking approval for Alpharadin (radium-223 dichloride (radium-223)) for the treatment of castration-resistant Prostate Cancer in patients with bone metastases. The treatment has been granted fast track designation by the FDA.

The submission was based on data from the ALSYMPCA trial, a Phase III, randomized, double-blind, placebo-controlled international study of radium-223 with BSC vs. placebo with BSC in symptomatic CRPC patients with bone metastases. The trial enrolled 921 patients in more than 100 centres in 19 countries. Treatment consisted of intravenous administrations of radium-223 or placebo each separated by an interval of four weeks. The primary endpoint was overall survival. Secondary endpoints included time to occurrence of skeletal-related events, time to total alkaline phosphatase (ALP) and prostate-specific antigen progression, total ALP response and normalization, safety, and quality of life.