地诺单抗在国内上市没呢？

Giant cell tumor of bone is composed of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptors. Its pathogenesis is that overexpression of RANKL causes tumor growth and bone destruction. RANKL is a transmembrane or soluble protein necessary for the formation, function, and survival of osteoclasts; osteoclasts are responsible for bone resorption, thereby regulating bone calcium release. Denosumab is a human immunoglobulin G2 (IgG2) monoclonal antibody with high specificity and affinity for RANKL. RANK receptor signaling promotes osteolysis and tumor growth. Denosumab inhibits tumor growth and reduces bone destruction by binding to RANKL and preventing it from activating RANK on the surface of osteoclasts, osteoclast precursors and osteoclast-like giant cells.

So has denosumab been launched in the country?

Amgen China recently announced that Angavir (English brand 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 Angarvi 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.

The approval of denosumab is based on the results of two open-label trials in patients with recurrent, unresectable giant cell tumor of bone or in whom planned surgical resection is likely to cause severe functional disability. The latest analysis of the study, presented at the European Society for Medical Oncology (ESMO) Annual Meeting in 2017, showed that among patients who could be surgically resected, 80% improved after treatment with neoadjuvant denosumab: 44% underwent surgery with less impact on function, and 37% avoided surgery. In unresectable patients, denosumab resulted in effective long-term disease control, with a 5-year progression-free survival (PFS) rate of 88%.

Common side effects include joint pain, headache, nausea, fatigue, back, hand and foot pain. The most common serious side effects are osteonecrosis of the jaw and osteomyelitis (inflammation or bone infection). Because denosumab is potentially harmful to the fetus, women of childbearing potential must use highly effective contraceptive measures when using this drug.