Is the number of cancer drug approvals a surrogate for regulatory success?

被引：20

作者：

Gyawali, Bishal ^{[1
,2
]}

Sharma, Shubham ^{[1
]}

Booth, Christopher M. ^{[1
]}

机构：

[1] Queens Univ, Canc Res Inst, Div Canc Care & Epidemiol, Kingston, ON, Canada

[2] Brigham & Womens Hosp, Program Regulat Therapeut & Law, 75 Francis St, Boston, MA 02115 USA

来源：

JOURNAL OF CANCER POLICY | 2019年 / 22卷

关键词：

Cancer drugs; FDA approval; Overall survival; Surrogate endpoint; Accelerated approval; Regular approval;

D O I：

10.1016/j.jcpo.2019.100202

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Both the speed of approval and efficacy of cancer drugs are important regulatory issues. Although the number of cancer drugs approved in a year is a marker of speed, whether it is also a marker of better outcomes remains unknown. In this study, we assess the trend in number and characteristics of 115 cancer drugs approved by the FDA over the last decade and evaluate whether they have improved patient survival. We find that the number of cancer drug approvals have steadily increased over the years from 5 in 2009 to 33 in 2018. Accelerated approvals started to rise since 2014 and peaked in 2017. The percentage of drugs that improved overall survival has steadily declined and reached its lowest (7 %) in 2017. Approval of better drugs that improve patient outcomes maybe more or at least equally important aspect for regulatory focus compared to approval of more number of drugs.

引用

页数：2