FDA Accepts Filing of NDA and Grants Priority Review for Radium Ra 223 for CRPC

Bayer Healthcare announced that the FDA has accepted its New Drug Application (NDA) for filing and has granted priority review of Radium Ra 223 Dichloride (radium-223) for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases. Radium Ra 223 dichloride (radium-223), formerly referred to as radium-223 chloride, is an investigational alpha particle-emitting pharmaceutical in development for CRPC patients with bone metastases.

Prostate cancer is the most common cancer among men in the United States other than skin cancer. About 16% of prostate cancer cases are considered regional or distant, which means that the cancer has metastasized beyond the prostate to nearby or distant areas of the body. A majority of men with CRPC have radiological evidence of bone metastases.  Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis. Bone metastases are the main cause of morbidity and death in patients with CRPC.

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