Bayer files radium-223 NDA with FDA for treatment of CRPC patients with bone metastases

Bayer HealthCare today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (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.

"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."

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. Fast track designation must be requested by the drug company and can be initiated at any time during the drug development process.