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Xgeva (denosumab) – EMA approves extension to existing indication: Prevention of bone complications of advanced cancers

On 22 February 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xgeva. The marketing authorisation holder for this medicinal product is Amgen Europe B.V.

The full indications for Xgeva will be as follows:

“Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.

Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Xgeva is a solution for injection that contains the active substance denosumab. It is available in single-use vials containing 120 mg denosumab.

The active substance in Xgeva, denosumab, is a monoclonal antibody. This is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body. Denosumab has been designed to attach to an antigen called RANKL, which is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue. By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts. This reduces the loss of bone, making fractures and other serious bone complications less likely to happen. The cells in giant cell tumour of bone are also activated via RANKL, and treatment with denosumab prevents them from growing and breaking down bone, allowing normal bone to replace the tumour.

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