Denosumab approved in Europe for treatment of SREs


Denosumab (Xgeva®) has been approved by the European Medicines Agency (EMEA) for the prevention of skeletal-related events (SREs) in adults with bone metastases from solid tumors, including prostate cancer, according to a media release issued by Amgen last Friday. Xgeva was approved for the same clinical indication by regulatory agencies in the USA and Canada some time ago.

“Skeletal-related events” whose frequency was lowered by treatment with denosumab in clinical trials included pathological fractures, the need for radiation therapy to bones, spinal cord compression or surgical intervention to stabilize bones.

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