The breakthrough therapy designation for promising cancer drugs is good for patients image

STAT, April 27, 2018
Jeff Allen, quoting Jonathan J. Darrow (Student Fellow Alumnus)

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From the article:

One exciting component of the Food and Drug Administration 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.

The NEJM article by Jonathan J. Darrow and his colleagues at Harvard Medical School was numb to both the actual patient experience and how patients may define a significant advance over an existing therapy. They argued that the FDA’s definition of all existing therapies allows drugs to be granted approval without showing benefit over appropriate comparators. If the FDA were to change how it views existing therapies, as Darrow and colleagues suggest, many drugs would be blocked from receiving the breakthrough designation, creating a bottleneck and limiting the benefits of the program to fewer drugs and, more importantly, to fewer patients.

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