弥漫大B细胞淋巴瘤治疗新药格菲妥单抗  

Glofitamab for diffuse large B cell lymphoma

作　　者：郑丽[1] 张凯华 孙雪林[3] ZHENG Li;ZHANG Kaihua;SUN Xuelin(Dept.of Pharmacy,China Aerospace Science&Industry Corporation 731 Hospital,Beijing 100074,China;Dept.of Thoracic Surgery,China Aerospace Science&Industry Corporation 731 Hospital,Beijing 100074,China;Dept.of Pharmacy,Beijing Hospital,Beijing 100730,China)

机构地区：[1]中国航天科工集团七三一医院药学部,北京100074 [2]中国航天科工集团七三一医院胸外科,北京100074 [3]北京医院药学部,北京100730

出　　处：《中国药房》2023年第24期3064-3067,共4页China Pharmacy

基　　金：中央高水平医院临床科研业务费专项(No.BJ-2023-200);国家重点研发计划(No.2020YFC2009001)。

摘　　要：弥漫大B细胞淋巴瘤(DLBCL)是一种来源于成熟B细胞的恶性肿瘤,目前其临床治疗以化学治疗为主,但仍有部分患者会在治疗后复发或进展为难治性DLBCL。2023年6月15日,美国FDA批准抗CD3/CD20双特异性单克隆抗体格菲妥单抗上市,为既往接受过二线或二线以上系统治疗后复发或进展为难治性DLBCL的患者提供了新的治疗方案。本文对格菲妥单抗的药理作用、临床研究、安全性及用法用量等进行了简要概述。格菲妥单抗主要通过促进T细胞的活化和增殖,激活T细胞释放肿瘤细胞杀伤蛋白,进而介导B细胞的裂解而发挥治疗DLBCL的作用。临床研究显示,格菲妥单抗对复发或难治性DLBCL具有较好的完全缓解率和客观缓解率,其常见不良反应包括轻/中度细胞因子释放综合征、肌肉骨骼疼痛、皮疹和疲劳,未见明显的药物相互作用。Diffuse large B cell lymphoma(DLBCL)is a malignant tumor derived from mature B cells.Currently,chemotherapy is still the main clinical treatment.However,some patients experience recurrence or refractory conditions after treatment.On June 15,2023,the FDA approved the marketing of glofitamab,a CD3/CD20 bispecific monoclonal antibody,to provide the new treatment plan for patients with recurrent or refractory DLBCL after receiving 2-line or above systemic treatment.This article reviews pharmacological effects,clinical studies,safety,usage and dosage of glofitamab.Glofitamab mainly plays a therapeutic role in DLBCL by promoting the activation and proliferation of T cells,activating T cells to release tumor cell-killing proteins,and mediating the lysis of B cells.Clinical studies have shown that glofitamab has a better complete and objective response rate for recurrent or refractory DLBCL.Common adverse reactions caused by glofitamab include mild/moderate cytokine release syndrome,musculoskeletal pain,rash,fatigue,and so on,without significant drug interactions.

关 键 词：格菲妥单抗 弥漫大B细胞淋巴瘤 抗CD3/CD20双特异性单克隆抗体 药理作用 临床研究 安全性 

分 类 号：R979.1[医药卫生—药品]