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The Accelerated Approval Program for Cancer Drugs -- Finding the Right Balance.

Authors :
Gyawali, Bishal
Kesselheim, Aaron S.
Ross, Joseph S.
Source :
New England Journal of Medicine. 9/14/2023, Vol. 389 Issue 11, p2-3. 4p.
Publication Year :
2023

Abstract

The article focuses on the Accelerated Approval Program for cancer drugs and the need to strike the right balance between expediting drug approvals based on surrogate measures and ensuring clinical benefits are confirmed in subsequent trials. Topics include the challenges and issues with the current program, proposed changes to the program, and the importance of safeguarding patient interests while accelerating drug development.

Subjects

Subjects :
*ANTINEOPLASTIC agents
*BIOMARKERS

Details

Language :
English
ISSN :
00284793
Volume :
389
Issue :
11
Database :
Academic Search Index
Journal :
New England Journal of Medicine
Publication Type :
Academic Journal
Accession number :
172011029
Full Text :
https://doi.org/10.1056/NEJMp2306872