"Dangling" Accelerated Approvals in Oncology

被引：63
|
作者：
Beaver, Julia A. [1 ]
Pazdur, Richard [1 ]
机构：
[1] US FDA, Oncol Ctr Excellence, Silver Spring, MD 20993 USA
来源：
NEW ENGLAND JOURNAL OF MEDICINE | 2021年 / 384卷 / 18期
关键词：
D O I：
10.1056/NEJMp2104846
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
"Dangling" Accelerated Approvals in Oncology The FDA recently reevaluated accelerated approvals for 35 oncology indications for anti-programmed death ligand 1 antibodies, revealing that for 10 indications, the required trials did not end up confirming benefit and yet their marketing authorization continued.
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页数：4
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