摘要
目的:分析1999-2014年美国FDA审批的首创性抗肿瘤新药。方法:本文在调研美国FDA网站相关数据库的基础上,系统梳理了1999-2014年美国FDA审批抗肿瘤新分子实体药物,并对审批的首创性抗肿瘤新药进行了深入的分析。结果和结论:1999-2014年美国FDA审批抗肿瘤新分子实体药物共计54个,首创性抗肿瘤新药19个,白血病、乳腺癌、肾癌、前列腺癌、肺癌和淋巴瘤类首创性新药较多。激酶类肿瘤分子靶向药物是近年来肿瘤药物研究的热点领域,也是首创性药物审批的热门。
Objective： To analyze the new entity anticancer drugs approved by the US Food and Drug Ad- ministration （FDA） in 1999-2014. Methods： We investigated the website and databases of US FDA, and ob- tained the approved drug information. Results and Conclusion： In the past fourteen years, the US FDA approved fifty-four new small-molecule anticancer drugs, including nineteen innovative anticancer new drugs. Most of the in- novative drugs are used for treating leukemia, breast cancer, kidney cancer, prostate cancer, lung cancer and lym- phoma. Kinase inhibitors are the hot area of anticancer research and the top of the approved innovative drugs.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2015年第10期1081-1090,共10页
Chinese Journal of New Drugs
关键词
美国FDA
肿瘤
新分子实体药物
新药
US Food and Drug Administration
cancer
new molecule entity
new drugs
