Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers

Abstract The Research to Accelerate Cures and Equity (RACE) for Children Act was enacted in 2017 to authorize the US Food and Drug Administration (FDA) to require pediatric studies for new cancer drugs that have a molecular target relevant to the growth or progression of a pediatric cancer. To asses...

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Bibliographic Details
Published in:JNCI : Journal of the National Cancer Institute 2020-03, Vol.112 (3), p.224-228
Main Authors: Hwang, Thomas J, Orenstein, Liat, DuBois, Steven G, Janeway, Katherine A, Bourgeois, Florence T
Format: Article
Language:English
Subjects:
Cancer
Cancer therapies
Cures
Drugs
Legislation
Pediatrics
Regulators
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Summary:Abstract The Research to Accelerate Cures and Equity (RACE) for Children Act was enacted in 2017 to authorize the US Food and Drug Administration (FDA) to require pediatric studies for new cancer drugs that have a molecular target relevant to the growth or progression of a pediatric cancer. To assess the possible scope of this new policy, we examined all 78 adult cancer drugs approved by the FDA from 2007 to 2017. Only 17 (21.8%) drugs received any pediatric labeling information. Based on the FDA’s Pediatric Molecular Target List, we found that the RACE Act could have increased the proportion of cancer drugs potentially subject to pediatric study requirements from 0% to 78.2%. However, the actual effect of the legislation will depend on how often regulators require pediatric trials and on timely completion of such trials.
ISSN:0027-8874
1460-2105
DOI:10.1093/jnci/djz207