Amgen has been boosted by the news that regulators in the European Union have given the green light to Xgeva for cancer-related fractures.
Specifically, the European Commission has granted marketing authorisation for Xgeva (denosumab) for the prevention of skeletal-related events in adults with bone metastases from solid tumours. The Commission has also granted the drug an additional year of data and market exclusivity in the European Union since the indication was considered new for denosumab and based on "the significant clinical benefit of Xgeva in comparison with existing therapies".
The thumbs-up is based on three Phase III head-to-head trials that evaluated Xgeva, a RANK ligand inhibitor, versus Novartis' intravenous infusion Zometa (zoledronic acid). In patients with breast or prostate cancer and bone metastases, denosumab proved superior in reducing the risk of SREs and non-inferior to Zometa in bone metastases due to other solid tumours or multiple myeloma.
Amgen quoted Ingo Diel of the Institute for Gynecological Oncology in Mannheim, Germany as saying that SREs associated with bone metastases "are truly devastating and painful for patients living with cancer", and the approval of Xgeva "marks a real advance". The drug has demonstrated sustained protection from SREs and also delayed the progression of pain, he added, saying that "these factors will make a genuine difference in the lives of patients living with advanced cancer".
Xgeva was approved in the USA last November and denosumab, under the brandname Prolia, is already marketed on both sides of the Atlantic for postmenopausal women with osteoporosis who are at high risk for fractures.