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XGEVA (denosumab)

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Benefits of XGEVA®

XGEVA® (DENOSUMAB) IS SUPERIOR TO ZOLEDRONIC ACID IN THE DELAY OR PREVENTION OF SREs IN ADULTS WITH BONE METASTASES FROM BREAST AND CASTRATION-RESISTANT PROSTATE CANCER [CHMP AR, p. 100]

The mechanism of action of XGEVA® in preventing the RANK/RANKL interaction is a successful strategy to decrease bone resorption and strengthen bones to prevent skeletal-related events (SREs) in adult patients with bone metastases from solid tumours. XGEVA® provides effective prevention of SREs including pathological fracture, radiation to bone, spinal cord compression or surgery to bone in adult patients with bone metastases from solid tumours. [CHMP AR, pp. 42, 101]

XGEVA® was superior to zoledronic acid in preventing or delaying SREs in two out of the three main clinical studies. This superiority was demonstrated in breast cancer patients with bone metastases and in castration-resistant prostate cancer patients with bone metastases, where an 18% risk reduction was observed in both groups. XGEVA® demonstrated superiority in adult patients with other solid tumours and bone metastases, other than breast and prostate cancer. However, in multiple myeloma patients, survival and disease progression in adult patients with bone metastases were worse with XGEVA® than zoledronic acid. XGEVA® is therefore not licensed for use in patients with multiple myeloma, and a clinical study is ongoing to clarify these results. [SmPC, pp. 10-11; CHMP AR, p. 101]