Bayer HealthCare receives CHMP backing for prostate cancer therapy

Bayer HealthCare has been granted a European regulatory recommendation for radium Ra 223 dichloride, a new therapy for a serious form of prostate cancer.

The European Committee for Medicinal Products for Human Use (CHMP) has endorsed the drug for use in the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

Data from the pivotal phase III trial Alsympca has demonstrated the safety and efficacy of the new therapy, which has already been approved for sale in the US under the brand name Xofigo.

It is expected that a final decision by the European Commission will be issued in the fourth quarter of 2013.

Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "Radium-223 exemplifies Bayer’s commitment to developing therapies with innovative mechanisms of action that can help address unmet patient needs."

The company is attending the European Cancer Congress in Amsterdam this week in order to share data on its latest oncology developments, including Ra 223.