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lüll Denosumab (Xgeva)äDenosumab (Xgeva)-/-CADTH Common Drug Reviews 2016[Nov]; ä (ä): äBone is a common site of metastasis for many cancers including breast, prostate, thyroid, lung, renal, and melanoma. Skeletal metastatic disease is the cause of considerable morbidity in patients with advanced cancer and has been associated with an increase in cancer-related pain, hypercalcemia, fractures, spinal instability, and compression of the spinal cord. Denosumab is a human monoclonal antibody binding to human receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab has a Health Canada indication for reducing the risk of developing skeletal-related events (SREs) in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours. Denosumab is not indicated for reducing the risk of developing SREs in patients with multiple myeloma. The drug plans that participate in the CADTH Common Drug Review (CDR) process have requested that denosumab be evaluated for reimbursement for reducing the risk of developing SREs in patients with bone metastases from solid tumours (except breast and prostate cancer). The objective of this report was to perform a systematic review of the beneficial and harmful effects of denosumab for reducing the risk of developing SREs in patients with bone metastases from solid tumours (except from breast cancer or prostate cancer).ä |