SNMMI Applauds FDA Approval of Radium-223 Dichloride (Xofigo)

May 16, 2013

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) commends the U.S. Food and Drug Administration (FDA) for its approval of radium-223 dichloride (Xofigo) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. 

The skeletal system is the number one metastatic site in patients with prostate cancer. Bone metastases occur when the primary cancer is transmitted through the blood and develops in the bone, often leading to bone pain, fractures, or other complications.

Radium-223 dichloride has a short range of penetration of alpha particles, sparing nearby healthy tissues and essential bone marrow. Radium-223 dichloride is the first alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival.

SNMMI encourages the FDA to continue reviewing and, when appropriate, approving other nuclear medicine and molecular imaging radiopharmaceuticals that can play a role in improving patient care.