Bayer HealthCare announced that the company has submitted a New Drug Application to the FDA seeking approval for radium Ra 223 dichloride (radium-223), an investigational compound for the treatment of patients with castration-resistant prostate cancer with bone metastases.
“If approved, radium-223 has the potential to play a key role in the treatment of men with [castration-resistant prostate cancer] that has metastasized to the bone,” said Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.
The submission was based on data from the ALSYMPCA trial, a phase III, randomized, double-blind, placebo-controlled international study of radium-223 with best supportive care vs placebo with best supportive care in symptomatic patients with castration-resistant prostate cancer 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 4 weeks.
The primary endpoint of the study was overall survival. Secondary endpoints included time to occurrence of skeletal-related events, time to total alkaline phosphatase and prostate-specific antigen progression, total alkaline phosphatase response and normalization, safety, and quality of life. ■