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XGEVA (denosumab)

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ABOUT XGEVA®

XGEVA® (denosumab) helps prevent skeletal-related events (SREs) in patients with bone metastases from solid tumours [SmPC, p. 2]

Bone metastases occur in over 1.5 million patients with cancer worldwide, and can result in severe clinical sequelae such as pathological fracture, radiation to bone, spinal cord compression, or surgery to bone. These events are collectively defined as SREs.[CHMP AR, p. 6]

XGEVA® is used to prevent SREs in adult patients with bone metastases from solid tumours.[SmPC, p. 2]

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]

PRESCRIBING XGEVA® (DENOSUMAB) TO YOUR PATIENTS

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XGEVA® (DENOSUMAB) Mechanism of Action

XGEVA® prevents the RANK/RANKL interaction, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction.[SmPC, p. 9]

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Clinical Studies of XGEVA® (DENOSUMAB)

The efficacy of XGEVA® compared with zoledronic acid in adults with advanced malignancies involving bone has been studied in three, extensive phase III studies: Study 1 in adults with breast cancer, Study 2 in adults with other solid tumours or multiple myeloma, and Study 3 in adults with castration-resistant prostate cancer.[SmPC, p. 9]

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Benefits of XGEVA® (DENOSUMAB)

XGEVA® treatment is superior to therapy with zoledronic acid in the delay or prevention of skeletal-related events (SREs) in adults with bone metastases from breast and castration-resistant prostate cancer. It has similar efficacy to zoledronic acid in adult patients with bone metastases from other solid tumours.[CHMP AR, p. 58]
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]

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