基于药动学方法支持用于肿瘤治疗的抗PD⁃1/PD⁃L1抗体可选给药方案的相关考虑  

Considerations on the alternative dosing regimens of anti⁃PD⁃1 or PD⁃L1 antibodies for treatment of patients with cancer based on pharmacokinetics

作　　者：刘美霞 马婧怡 刘淑洁 刘少丹 贺锐锐 LIU Mei-xia;MA Jing-yi;LIU Shu-jie;LIU Shao-dan;HE Rui-rui(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2024年第21期2228-2233,共6页Chinese Journal of New Drugs

摘　　要：为提高患者的依从性和给药的便利性,已有不少用于肿瘤治疗的抗程序性死亡受体1(pro⁃grammed cell death receptor⁃1,PD⁃1)/程序性死亡配体1(programmed cell death⁃ligand 1,PD⁃L1)抗体在研发过程中或获批上市后,通过改变给药剂量和/或给药间隔,提供更多可供选择的给药方案。本文结合国内外相关指导原则、已获批案例及该类品种在审评过程中出现的问题,对基于药动学方法支持用于肿瘤治疗的抗PD⁃1/PD⁃L1抗体可选给药方案的关注要点进行分析,以期为业界在探索用于肿瘤治疗的抗PD⁃1/PD⁃L1抗体可选给药方案时提供参考。In order to improve the compliance of patients and convenience of drug administration,a number of anti⁃PD⁃1/PD⁃L1 antibodies for cancer treatment have been developed during the development process or after the approval.More dosing regimens can be provided by varying the dosage and dosing intervals.Based on the relevant guidelines in China and abroad,the approved cases and the problems in the application process of alternative dosing regimens of anti⁃PD⁃1/PD⁃L1 antibodies for treatment of patients with cancer.This article analyzes the key focus points to support the alternative dosing regimen of anti⁃PD⁃1/PD⁃L1 antibody for tumor treatment based on pharmacokinetic methods,in order to provide references for the sponsors to explore the alternative dosing regimen of anti⁃PD⁃1/PD⁃L1 antibody for tumor treatment.

关 键 词：抗PD⁃1/PD⁃L1抗体 给药方案 群体药动学 剂量/暴露⁃效应 

分 类 号：R979.1[医药卫生—药品]