The marketing authorization was granted on the basis of the results of three Phase 3 trials evaluating XGEVA versus zoledronic acid at delaying SREs.
The results of the trial showed clinically meaningful improvement in preventing SREs in comparison to zoledronic acid.
Additionally, the company has also received XGEVA an additional year of data and market exclusivity in the EU since the indication was considered new for denosumab and based on the clinical benefit of XGEVA as compared to existing therapies.