地舒单抗治疗骨巨细胞瘤的效果

The injection is a human immunoglobulin G2 (IgG2) monoclonal antibody with high specificity and affinity for RANKL. RANK receptor signaling promotes osteolysis and tumor growth. Desosumab injection 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.

The approval of this indication for denosumab injection 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 with neoadjuvant denosumab: 44% underwent surgery with less functional impact 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%10.

Desosumab Injection’s clinical import-free registration application in China is supported by overseas clinical data, and the main supporting clinical data were obtained overseas. The State Food and Drug Administration integrated the opinions of various technical departments and conditionally approved the listing on May 21. At the same time, it is required to continue clinical research in China after the product is approved, and formulate and strictly implement a risk management plan.

The above is an introduction to the effect of treating giant cell tumor of bone. For more information about denosumab, please contact Medical Companion Travel for details.