FDA approval standards for anticancer agents - lessons from two recent approvals in breast cancer

被引：5
|
作者：
Gyawali, Bishal [1 ,2 ,3 ,4 ]
Kesselheim, Aaron S. [1 ]
机构：
[1] Harvard Med Sch, Brigham & Womens Hosp, Program Regulat Therapeut & Law PORTAL, Boston, MA 02115 USA
[2] Queens Univ, Dept Oncol, Kingston, ON, Canada
[3] Queens Univ, Dept Publ Hlth Sci, Kingston, ON, Canada
[4] Queens Univ, Div Canc Care & Epidemiol, Kingston, ON, Canada
来源：
NATURE REVIEWS CLINICAL ONCOLOGY | 2021年 / 18卷 / 07期
关键词：
D O I：
10.1038/s41571-021-00504-1
中图分类号：
R73 [肿瘤学];
学科分类号：
100214 ;
摘要：
Two recent drug approvals for metastatic breast cancer highlight that the evidence standards required to support FDA approval seem to be decreasing. These two drugs not only failed to improve overall survival, but their effects on progression-free survival were also astonishingly low; in one case, the treatment delayed progression by only 3 days.
引用
收藏
页码：397 / 398
页数：2
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