Dinutuximab是一种可与神经母细胞瘤表面结合的嵌合单克隆抗体,是首个专门治疗高危神经母细胞瘤患者的药物。美国FDA授予其优先审评和孤儿药资格,并批准其上市,作为一线治疗药物的一部分,用于高危神经母细胞瘤儿科患者。本文对其作用机制、药动学、临床研究、安全性等进行综述。 Dinutuximab, a chimeric monoclonal antibody that binds to the surface of neuroblastoma, is the first drug specifically designed to treat high-risk neuroblastoma patients. The US FDA grants priority review and orphan drug eligibility and approves its listing as part of first-line treatment for pediatric patients with high-risk neuroblastoma. This article reviews its mechanism of action, pharmacokinetics, clinical research, safety and so on.