The U.S. Food and Drug Administration has granted priority review to Radium Ra 223 Dichloride (radium-223) for the treatment of patients with castration-resistant prostate cancer with bone metastases.
The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act.
Prostate cancer is the second most common cancer in men in the U.S. (after skin cancer), and a majority of patients with castration-resistant disease have evidence of bone metastases.
Radium-223, an alpha particle-emitting pharmaceutical, is being co-developed and co-commercialized by Bayer HealthCare and Algeta ASA.