Approval of Xofigo was accelerated under priority review program
A new prostate cancer treatment drug, Xofigo (radium Ra 223 dichloride), has been approved by the FDA for use in men with symptomatic late-stage castration-resistant prostate cancer that has metastasized only to bones.
According to Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, “Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues.”
In a clinical trial involving 809 men with symptomatic castration-resistant prostate cancer that had metastasized only to bones, researchers found that when compared with patients taking placebo plus best standard of care, overall survival was extended among those receiving Xofigo.
Source: FDA News Release.