Amgen receives EU approval for Xgeva

Amgen has been granted European marketing authorisation for Xgeva, its treatment for the prevention of skeletal-related events in adults with bone metastases from solid tumours.

The drug has been ratified for this specification by the European Commission based on positive data from three pivotal phase III clinical trials, in which the therapy demonstrated efficacy benefits when compared to zoledronic acid.

In addition, Xgeva was also granted an additional year of data and market exclusivity in the EU, based in part on the significant advantages it offers over existing therapies.

Dr Willard Dere, senior vice-president and international chief medical officer at Amgen, said this represents the culmination of several years' worth of research by its scientists.

"Xgeva promises to make a real difference for patients with cancer whose daily lives are affected by the consequences of bone metastases," he added.

Earlier this month, the company announced a new alliance with Micromet to study BiTE antibodies with potential applications against cancer.