The CHMP positive opinion is based on three pivotal, Phase 3 head-to-head trials that evaluated the effectiveness of XGEVA versus Zometa (zoledronic acid) at delaying skeletal-related events (SREs).
In the SRE trials, XGEVA improved in preventing SREs compared to Zometa.
Amgen senior vice president and international chief medical officer Willard Dere said XGEVA offers the ease of every four weeks subcutaneous injection and no requirement for dose adjustment for changes in renal function.
The CHMP also recommended to grant XGEVA an additional year of data and market exclusivity in the EU since the indication was considered significantly new for XGEVA, and based on the clinical benefit of the product in comparison with existing therapies.
Amgen has also submitted marketing applications for XGEVA in Australia, Mexico, Russia and Switzerland.