FDA Gives Radium-223 Priority Review Status

February 19, 2013

Radium Ra 223 Dichloride, an alpha radiation-emitting drug also known as radium-223, will be considered as a treatment for patients who have castration-resistant prostate cancer (CRPC) with bone metastases under the FDA’s priority review program.

The FDA grants priority review to drugs that may represent a significant improvement over existing treatments for a condition, or when there is no adequate therapy. The agency’s goal is to complete priority reviews within six months of the 60-day filing receipt of a new drug application, or a total of eight months.