Posted by Michael Wonder on 27 Apr 2018
The breakthrough therapy designation for promising cancer drugs is good for patients
27 April 2018 - One exciting component of the FDA Safety and Innovation Act was the creation of the breakthrough therapy designation.
It allows an all-hands-on-deck approach at the FDA to determine the best path forward when the early clinical promise of a drug is so significant and meaningful beyond existing therapies — or lack of other meaningful therapies — for serious or life-threatening illnesses. Although the validity of the breakthrough designation was questioned recently in a tone-deaf article in the New England Journal of Medicine, this designation has provided patients with tremendous benefit since it was passed into law in 2012.
First, drugs that receive the breakthrough therapy designation are developed significantly faster than those that don’t. A 2016 analysis by my organisation, Friends of Cancer Research, found that breakthrough-designated drugs were developed more than two years faster than non-designated drugs. This difference in development time is substantial and increases access to new therapies among patients with serious or life-threatening diseases.
