地诺单抗获批适应症有什么？

The European Union approved (denosumab) on July 19, 2011 for the treatment of adult patients with solid tumors and bone metastases, but it is not suitable for hematological tumors. Denosumab is a monoclonal antibody that specifically targets receptor activator of nuclear factor i-κB ligand (RANKL). It can inhibit the activation and development of osteoclasts, reduce bone resorption, and increase bone density. Denosumab was earlier used to treat osteoporosis in postmenopausal women with a higher risk of fractures, with good safety and effectiveness. On May 27, 2019, denosumab was approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or where surgical resection may cause severe functional disability, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).

Its current new indications are: prevention of bone-related events (SREs, including bone pain, pathological fractures, spinal cord compression, hypercalcemia, and bone complications requiring surgery or radiotherapy, etc.).

Three studies compared denosumab with zoledronate in breast cancer, prostate cancer, and other solid tumors (including multiple myeloma) with bone metastases. A comprehensive analysis of these three clinical studies showed that compared with zoledronate, denosumab can prolong the time to first SRE, the median time to first SRE, and the time interval from first SRE to recurrence in enrolled patients, and denosumab can more effectively prevent the progression of related bone pain.

In addition, (denosumab) can only be injected subcutaneously, not intravenously, intramuscularly, or intradermally. (2) Solid tumor bone metastasis: 120mg once every 4 weeks, injected subcutaneously in the upper arm, thigh or abdomen. (3) Giant cell tumor of bone: 120 mg once every 4 weeks, subcutaneous injection, and then 120 mg on d8 and d15 in the first month of treatment. (4) Administer calcium and vitamin D appropriately to prevent hypocalcemia.