晚期非小细胞肺癌表皮生长因子受体酪氨酸激酶抑制剂临床研发和审评考虑  

Clinical research and drug review of epidermal growth factor receptor tyrosine kinase inhibitors in advanced non-small cell lung cancer

作　　者：周明 陈东梅 夏琳 宋媛媛 石远凯 杨志敏 Zhou Ming;Chen Dongmei;Xia Lin;Song Yuanyuan;Shi Yuankai;Yang Zhimin(Center for Drug Evaluation,China National Medical Products Administration,Beijing 100022,China;National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs,Beijing 100021,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]国家癌症中心国家肿瘤临床医学研究中心中国医学科学院北京协和医学院肿瘤医院抗肿瘤分子靶向药物临床研究北京市重点实验室,100021

出　　处：《中华肿瘤杂志》2019年第12期949-952,共4页Chinese Journal of Oncology

摘　　要：肺癌位居中国恶性肿瘤发病率和死亡率首位。非小细胞肺癌约占全部肺癌的85%。中国肺癌EGFR基因突变发生率高,约占全部NSCLC的32%~38%。近10年来,表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)的应用明显改善了具有EGFR基因敏感突变的晚期肺癌患者的预后。在这样的背景下,国内第三代EGFR-TKI的研发进入快速发展期,已有靶向EGFR C797S的第四代EGFR-TKI进入临床。文章将从临床审评角度,阐述晚期肺癌EGFR-TKI临床研发的审评考虑。Lung cancer is the most frequently diagnosed cancer and the most common cause of cancer mortality in China.Non-small cell lung cancer(NSCLC)accounts for about 85%of lung cancers.The mutation rate of epidermal growth factor receptor(EGFR)gene is relatively high,accounts for 32%~38%of all NSCLC.During the last decade,the application of EGFR specific tyrosine kinase inhibitors(TKI)significantly improved prognosis of NSCLC patients with sensitive EGFR mutations.Thus,the research and development of third generation EGFR-TKI have entered the period of rapid development.The fourth generation EGFR-TKI which targeting EGFR C797S has even begun clinical development in China.This review will discuss the clinical research and drug review of EGFR-TKI from the perspective of drug review.

关 键 词：癌 非小细胞肺癌 表皮生长因子受体酪氨酸激酶抑制剂 创新药 临床研发 技术审评 

分 类 号：R734[医药卫生—肿瘤]