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(denosumab, also known as AMG-162, trade name Prolia) is a bone resorption inhibitor with a unique mechanism of action. It specifically targets receptor activator of nuclear factor kappa B (RANK) ligand, inhibits the activation and development of osteoclasts, reduces bone resorption, and increases bone density. On May 28, 2010, the European Commission approved denosumab for the treatment of bone loss associated with hormone suppression in postmenopausal women with osteoporosis and prostate cancer. It can also be used in patients who are currently ineffective or intolerant to other treatments to reduce the risk of fractures. Denosumab was approved for the first time in 27 EU member states, as well as Norway, Iceland, and Liechtenstein. In June of the same year, denosumab was approved by the FDA.

In 2013, the FDA approved it for the treatment of adults and skeletally mature adolescents with giant cell tumors that are unresectable or may lead to severe mortality after surgery.

On May 23, 2018, the U.S. FDA approved a new indication for Amgen’s denosumab, allowing the drug to be used to treat glucocorticoid-induced osteoporosis (GIOP), suitable for male and female patients at high risk of fractures.  

On May 27, 2019, Amgen China announced today that Engavir® (English trade name: In 2018, denosumab was included in the list of overseas new drugs in urgent clinical need (first batch) and entered the rapid review channel of the National Medical Products Administration. This approval makes denosumab the first and currently the only drug in China for the treatment of giant cell tumor of bone, bringing patients an innovative treatment option to control disease progression and improve quality of life.

Hypocalcemia must be corrected before denosumab therapy can be initiated. For patients who are prone to hypocalcemia and mineral metabolism imbalance (such as those with a history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malnutrition, small bowel resection, severe renal insufficiency), clinical monitoring of creatinine and mineral levels is required, and such patients should be instructed to pay attention to the symptoms of hypocalcemia and to supplement adequate amounts of calcium and vitamin D. Patients who are concurrently taking immunosuppressants or have compromised immune systems may be at increased risk of serious infections, and physicians need to fully consider the benefit-risk ratio before prescribing denosumab to such patients. Physicians should evaluate the need to continue denosumab therapy in patients who develop serious infections during use.