Little Benefit to Breakthrough Cancer Drugs image

Cancer Discovery, May 16, 2018
Catherine Caruso, quoting Jonathan J. Darrow (Student Fellow Alumnus)


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From the article:

In 2012, the FDA created the breakthrough therapy designation to speed up the development and review of drugs intended to treat serious or life-threatening diseases when preliminary clinical evidence indicates a possible substantial improvement over existing therapies. However, a recent analysis of breakthrough-designated cancer drugs indicates that although they are approved more quickly, they are no more effective, safe, or novel than drugs approved via the traditional pathway.

Because 59% of cancer medicines approved since 2014 have received that designation, researchers wanted to assess the value of these drugs, explains Jonathan Darrow, SJD/JD, MBA, of Harvard Medical School and Brigham and Women's Hospital, both in Boston, MA, and senior author of the study.

Darrow and his colleagues analyzed 58 cancer drugs approved by the FDA between January 2012 and December 2017, 25 of which received breakthrough therapy designation. The median time to FDA approval was 5.2 years for breakthrough therapies, versus 7.1 years for drugs without the designation. There was no significant difference between the two categories of drugs in median progression-free survival gains (8.6 vs. 4 months) or response rates (37% vs. 39%). Nor were breakthrough therapy–designated drugs more likely to have a novel mechanism of action (36% vs. 39%). Further, rates of death (6% vs. 4%) and serious adverse events (38% vs. 36%) were similar.

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