Pediatric trials for cancer therapies with targets potentially relevant to pediatric cancers

Thomas J. Hwang, Liat Orenstein, Steven G. DuBois, Katherine A. Janeway, Florence T. Bourgeois

Research output: Contribution to journalReview articlepeer-review

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.

Original languageEnglish
Article numberdjz207
Pages (from-to)224-228
Number of pages5
JournalJournal of the National Cancer Institute
Volume112
Issue number3
DOIs
StatePublished - 2021
Externally publishedYes

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