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J Natl Cancer Inst. 2019 Oct 29. pii: djz207. doi: 10.1093/jnci/djz207. [Epub ahead of print]

Pediatric Trials for Cancer Therapies with Targets Potentially Relevant to Pediatric Cancers.

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Harvard Medical School, Boston, MA.
Pediatric Therapeutics and Regulatory Science Initiative, Computational Health Informatics Program, Boston Children's Hospital, Boston, MA.
Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, MA.
Department of Pediatrics, Harvard Medical School, Boston, MA.


The Research to Accelerate Cures and Equity (RACE) for Children Act was enacted in 2017 to authorize the 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 2007-2017. 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 impact of the Act will depend on how often regulators require pediatric trials and on timely completion of such trials.


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