Pediatric Oncology Drug Studies Boosted by RACE Act, FDA Says

In an analysis that seeks to help frame the discussion at the upcoming Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, the FDA says that a law enacted in 2017 has increased the number of planned studies to test drugs for pediatric cancers compared to earlier regulatory laws.

The Research Acceleration for Cure and Equity (RACE) for Children Act, enacted as part of the 2017 FDA Reauthorization Act (FDARA) supported the FDA’s issuance of 131 investigational Pediatric Study Plans from 2020-2023, the agency said. Most of these (86 percent) included plans for a full or partial waiver or a deferral of the requirement to conduct a pediatric study under the prior regulatory guidance of the Pediatric Research Equity Act (PREA).

Over the same time period, 22 postmarketing requirements for pediatric studies were issued under PREA, the FDA noted. These were linked to 17 unique drug applications. Fourteen of the 17 approved applications were original applications for new targeted therapies.

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