THOUSAND OAKS, Calif., July 15, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the European Commission (EC) has granted marketing authorization for XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. This approval of XGEVA applies to all 27 European Union (EU) member states. The EC also granted XGEVA an additional year of data and market exclusivity in the EU since the indication was considered new for denosumab and based on the significant clinical benefit of XGEVA in comparison with existing therapies.
Bone metastases, the spread of cancer to the bones, are a common and serious concern for patients with advanced cancer and present a burden to the healthcare system. Weakened bones due to metastases can lead to SREs. The primary goal of treatment for bone metastases is to prevent the occurrence of these debilitating and costly SREs.
"Skeletal-related events associated with bone metastases are truly devastating and painful for patients living with cancer, and today's approval of XGEVA marks a real advance," said Professor Ingo J. Diel, M.D., Institute for Gynecological Oncology, SPGO, Mannheim, Germany. "In clinical trials XGEVA demonstrated sustained protection from SREs and also delayed the progression of pain. These factors will make a genuine difference in the lives of patients living with advanced cancer."
The marketing authorization for XGEVA is based on three pivotal, Phase 3 head-to-head trials that evaluated the effectiveness of XGEVA versus zoledronic acid at delaying SREs. The SRE clinical program for XGEVA spanned more than 50 tumor types in over 5,700 patients. In the SRE trials, XGEVA demonstrated a clinically meaningful improvement in preventing SREs compared to zoledronic acid. In these trials, XGEVA was administered every four weeks as a 120 mg subcu