CHMP recommends radium Ra 223 dichloride for Prostate Cancer
Bayer HealthCare has announced that the European Committee for Medicinal Products for Human Use (CHMP) has on 20 September 2013, recommended radium Ra 223 dichloride (radium-223) for approval with a proposed indication for the treatment of adults with castration-resistant Prostate Cancer, symptomatic bone metastases and no known visceral metastases. The CHMP recommendation is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. The decision of the European Commission on the approval is expected in the fourth quarter of 2013.
Radium-223 was approved by the FDA in May under the brand name Xofigo.
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