Xgeva denosumab regulatory update

The European Commission approved Xgeva denosumab from Amgen to prevent skeletal-related events in adults with bone metastases from solid tumors. The EC also granted an additional year of market exclusivity in the EU since the indication is considered significantly new for denosumab and because there is significantly greater clinical benefit of Xgeva compared with existing therapies in the indication. Xgeva is approved in the U.S. for the indication. The drug is also approved as Prolia in the U.S. and EU to treat osteoporosis in postmenopausal women and in the EU to treat bone loss associated with hormone ablation in men with prostate cancer. Denosumab is a human mAb targeting receptor activator of NF-kappa B ligand ( RANKL). ...