小分子靶向抗肿瘤药物临床研究策略探讨及案例分析  

Discussion and case analysis of clinical development strategy of small-molecule targeted anti-cancer drugs

作　　者：陈晓媛[1] 张虹[1] 高晨燕[1] 杨志敏[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2013年第3期269-273,共5页Chinese Journal of New Drugs

摘　　要：小分子靶向抗肿瘤药物是当前国内外创新药研发的热点,近些年不断有新产品上市,还有数百个产品正处于临床研发阶段。因为作用机制的不同,小分子靶向药物体现出与传统细胞毒类药物不一样的安全有效性特点,在临床研究设计和开发模式上也有所不同。本文对近年来批准上市的吉非替尼、克唑替尼、埃克替尼等小分子靶向药物临床研究经典案例进行了回顾,分析不同类型药物的临床研发策略,期望能对抗肿瘤药物相关研发人员提供参考。Small molecule targeted anti-cancer drugs have been a worldwide focus of research and develop- ment of innovative drug currently. In recent years, new drug products have got into the market in succession and hundreds of new compound are still in developing phase. Because of different mechanisms of action, the profiles of efficacy and safety of small molecule targeted anti-cancer drugs are different from traditional cytotoxic agents as well as their clinical development modes and trial designs. We reviewed some typical cases of clinical development such as gefitinib, critizonib and icotinib in this paper, and discussed the development strategies for different types of small molecule targeted anti-cancer drugs in order to provide useful reference for related researchers in this area.

关 键 词：小分子靶向抗肿瘤药 临床研究 吉非替尼 克唑替尼 埃克替尼 

分 类 号：R95[医药卫生—药学]