Bayer HealthCare announced that the company has submitted a New Drug Application (NDA) to the FDA seeking approval for radium Ra 223 dichloride (radium-223), an investigational compound for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases. Radium Ra 223 dichloride, formerly referred to as radium-223 chloride, is an alpha particle emitting pharmaceutical.
Radium-223 was granted fast track designation by the FDA. The fast track process is designed to facilitate the development and expedited review of drugs to treat serious diseases and fill an unmet medical need.
The submission was based on data from the ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, a Phase 3, 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 >100 centers in 19 countries. The study treatment consisted of up to six intravenous administrations of radium-223 or placebo each separated by an interval of four weeks. The primary endpoint of the study was overall survival.
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