FDA approves Xofigo (Bayer HealthCare) for Prostate Cancer

The FDA has approved Xofigo (radium Ra 223 dichloride), from Bayer HealthCare, for the treatment of patients with castration-resistant Prostate Cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo (formerly Alpharadin) is the first and only alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event compared to placebo.

The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA trial. At the interim analysis, Xofigo significantly improved overall survival, median OS was 14.0 months with Xofigo plus best standard of care vs. 11.2 months with placebo plus best standard of care. Additionally, at the interim analysis there was a delay in time to first symptomatic skeletal event for patients treated with Xofigo vs. placebo. An updated analysis, conducted after the study was unblinded, showed improvement in overall survival, with a median OS of 14.9 months vs. 11.3 months. Xofigo was filed in the EU in December 2012.