The FDA has approved Xofigo (radium Ra 223 dichloride; Bayer) injection for the treatment of symptomatic late-stage castration-resistant prostate cancer with bone metastases, and no known visceral metastatic disease. Xofigo is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. This alpha-particle emitting pharmaceutical was granted priority review in February 2013. Xofigo mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases.
Xofigo’s safety and efficacy were evaluated in the Phase 3 ALSYMPCA trial of 809 male patients with symptomatic castration-resistant prostate cancer with bone metastases. Patients were randomized to receive Xofigo or placebo plus best standard of care. The study’s primary endpoint was overall survival. Results from a pre-planned interim analysis showed male patients receiving Xofigo lived a median of 14 months, compared to a median of 11.2 months for men receiving placebo. An exploratory updated analysis confirmed Xofigo’s ability to extend overall survival.
Xofigo injection is expected to be available within a few weeks.
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