Denosumab indications

Clinical treatment methods for bone metastases are limited, and systemic treatment is difficult to control. Moreover, most of them are osteolytic bone metastases, and bone destruction is difficult to reconstruct. The most important treatment is regular intravenous administration of bisphosphonates once a month. Today, the editor will introduce to you a subcutaneous injection drug that has better anti-bone metastasis effect than traditional bisphosphonates - (Xgeva, denosumab), also known as denosumab. The drug has been approved by the FDA and is included in NCCN guidelines.

Denosumab mechanism of action: RANKL is a transmembrane or soluble protein that plays an important role in the formation, function, survival and cells of osteoclasts responsible for bone resorption, regulating the release of calcium from bone. Through RANKL stimulation, osteoclast activity is enhanced, mediating the occurrence of bone metastasis bone pathology in solid tumors. Denosumab can bind to the RANKL protein, preventing RANKL from binding to the receptor RANK expressed on the surface of osteoclasts, precursor cells, and osteoclast-like giant cells to activate subsequent malignant processes, thus exerting an anti-bone metastasis effect. 

Denosumab is currently approved for three indications: (1) Prevention of bone-related events in bone metastases from solid tumors, except for patients with multiple myeloma. Instructions for use: 120mg, once every 4 weeks. Also infuse calcium or vitamin D to prevent hypocalcemia. (2) Unresectable or surgical resection of giant cell tumor of bone in adults or bone-mature adolescents may cause serious complications. Instructions for use: 120mg, once every 4 weeks. In the first month of treatment, add 120mg on the 8th and 15th days respectively. (3) Hypercalcemia in bisphosphonate-resistant malignant tumors. The usage method is the same as the second indication.

   On May 23, 2019, China’s National Medical Products Administration announced conditional approval of the import registration application for Denosumab Injection (English name: Denosumab Injection). It is intended for the treatment of adults and skeletally mature adolescent patients with unresectable giant cell tumors of bone or whose surgical resection may result in severe functional impairment.