Bayer HealthCare receives EU backing for cancer drug Xofigo

Bayer HealthCare has announced that the European Commission has granted regulatory approval for its new oncology agent Xofigo.

The drug has been approved for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases, following a positive recommendation from the Committee for Medicinal Products for Human Use.

Data from the pivotal phase III trial Alsympca were announced earlier this year, showing Xofigo reduced the risk of death among this patient group by 30.5 percent compared to placebo, thus meeting its primary efficacy endpoint in the study.

The compound functions by targeting bone metastases and delivering a localised cytotoxic effect to offer patients prolonged survival, making it a potentially important advance for sufferers of this painful and dangerous disease.

Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "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."