European regulator clears Bayer, Algeta's Xofigo for prostate cancer

Bayer announced Friday that the European Commission approved Xofigo (radium 223 dichloride) for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. The FDA cleared the alpha particle-emitting pharmaceutical, which was developed in partnership with Algeta, in May.

According to Bayer, the decision follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use in September and is based on data from the Phase III ALSYMPCA trial. "As the latest addition to Bayer’s growing oncology franchise and following a quick approval in the US, we are pleased that Xofigo is now available to patients in Europe," remarked Kemal Malik, Bayer's head of global development.

In 2009, Bayer and Algeta signed a deal potentially worth up to $800 million to develop Xofigo, with the companies jointly promoting the drug in the US and sharing profits.

For related analysis, see ViewPoints: Combination use beckons for Bayer's newly approved prostate treatment Xofigo say experts, if radioactivity concerns can be overcome and FirstWord Therapy Trends - KOL Insight: Prostate Cancer - Competition intensifies in race to the top.

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