EU approval for Bayer's prostate cancer drug Xofigo

15 November 2013

The European Commission has granted marketing authorization for German drug and chemical major Bayer’s (BAYN: DE) Xofigo solution for injection (radium Ra 223 dichloride) for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

The drug, developed with originator Norway’s Algeta (OSE: ALGETA), was approved in the USA in the spring and was launched there almost immediately (The Pharma Letter May 30).This EC decision follows a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) in September of this year. The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.

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