XGEVA® (denosumab) is a monoclonal antibody that binds to RANKL, inhibiting osteoclast activity [SmPC, p. 9]
XGEVA® is a human monoclonal antibody that works by inhibiting the RANK/RANKL interaction, reducing osteoclast number and function, and thereby reducing cancer-induced bone resorption. The benefits of using XGEVA® in adult patients with bone metastases from solid tumours have been shown in clinical studies.[SmPC, pp. 2, 8]
At present, several bisphosphonates are approved for the prevention of SREs or treatment of osteolytic lesions in adult patients with advanced cancer and bone metastases. XGEVA® has shown a superior effect compared to zoledronic acid based on two of three clinical studies, in patients with advanced breast cancer and bone metastases, and in patients with prostate cancer and bone metastases.[CHMP AR, pp. 6, 73]
XGEVA® is also used to treat 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.[SmPC, p. 2]