European regulators approved Amgen’s Xgeva (denosumab) for the prevention of
skeletal-related events (SREs) in adults with bone metastases from solid
tumours, the company reported Friday. In making its decision, which followed a
positive recommendation in May, the European Commission also
granted the compound an additional year of market exclusivity.
The company noted that the approval was based on data from three late-stage
studies, in which Xgeva demonstrated a “clinically meaningful improvement” in
preventing SREs compared to Novartis’ Zometa (zoledronic acid). According to
Amgen, in patients with breast or prostate cancer, Xgeva was shown to be
superior to Zometa in reducing the risk of SREs, while in those with bone
metastases due to other solid tumours or multiple myeloma, the RANK ligand
inhibitor was non-inferior to Novartis’ drug.
Xgeva is also approved in this indication in the US and Canada, while in Japan, Amgen’s partner Daiichi Sankyo
submitted a marketing application last year.