摘要
MYLOTARG(gemtuzumab ozogamicin)是辉瑞公司开发的一种靶向CD33抗原的抗体偶联药物。该药于2017年9月1日被FDA批准重新上市,用于治疗CD33阳性的急性髓细胞白血病。在对新诊断为CD33阳性急性髓细胞白血病患者进行的联合用药Ⅲ期临床试验中,MYLOTARG组平均无事件生存期为17.3个月,对照组为9.5个月,无事件生存期显著延长。MYLOTARG可作为治疗CD33阳性急性髓细胞白血病的新选择。本文对MYLOTARG的基本信息,理化性质,药动学,临床试验等信息作一概述。
MYLOTARG(gemtuzumab ozogamicin) is an antibody-drug conjugate produced by Pfizer that targets the CD33 antigen. The drug was reapproved by the FDA on September 1, 2017 for the treatment of CD33 positive acute myeloid leukemia. The PhaseⅢ clinical trial of combination therapy in newly diagnosed patients with CD33-positive acute myeloid leukemia showed a significantly longer event-free survival as 17.3 months in the MYLOTARG group and 9.5 months in the control group. Therefore, MYLOTARG is a new treatment for CD33 positive acute myeloid leukemia. This article summarizes the basic information, physicochemical properties, pharmacokinetics and clinical trials of MYLOTARG.
作者
栾思睿
李家国
谢菲
LUAN Si-rui;LI Jia-guo;XIE Fei(College of Pharmacy, Jilin University, Changchun 130021, China;National Engineering Research Center for the Strategic Drug, Institute of Pharmacology and Toxicology of AMMS, Beijing 100850, China)
出处
《临床药物治疗杂志》
2018年第3期22-27,共6页
Clinical Medication Journal