Bayer HealthCare has submitted a New Drug Application (NDA) to the FDA seeking approval for radium Ra 223 dichloride (radium-223), a fast tracked investigational compound for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases.
Radium Ra 223 is an alpha particle emitting pharmaceutical and was granted Fast Track designation by the FDA.
“If approved, radium-223 has the potential to play a key role in the treatment of men with CRPC that has metastasized to the bone,” said Pamela A. Cyrus, MD, vice president and head of U.S. medical affairs, Bayer HealthCare Pharmaceuticals. “The development of a compound like radium-223 is an example of Bayer’s commitment to investing in approaches to treat hard-to-treat cancers.”
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 versus placebo with BSC in symptomatic CRPC patients with bone metastases. The trial enrolled 921 patients in more than 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. Secondary endpoints included time to occurrence of skeletal-related events (SRE), time to total alkaline phosphatase (ALP) and prostate-specific antigen (PSA) progression, total ALP response and normalization, safety, and quality of life.