# RACE for Children Act

Source: https://onco.cc/terms/race-for-children-act/  
OnCo record `race-for-children-act` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A US law that makes drug companies test new targeted cancer drugs in children whenever the drug's target matters in a childhood cancer, instead of letting them skip children because their cancers are rare.

## Summary

The RACE for Children Act was enacted as Title V of the FDA Reauthorization Act (FDARA) of 2017 and took effect for applications submitted from 18 August 2020. It amended the Pediatric Research Equity Act (PREA) so that a new drug or biologic for an adult cancer must include a paediatric investigation if it is directed at a molecular target that the FDA judges 'substantially relevant to the growth or progression of a pediatric cancer', and it removed the orphan-drug exemption from PREA for such products. The FDA Oncology Center of Excellence maintains the relevant and non-relevant molecular target lists (updated after Pediatric Oncology Subcommittee of ODAC meetings) and issues written requests and waivers. The Act complements the EU Paediatric Regulation (EC 1901/2006), whose paediatric investigation plans (PIPs) had allowed class waivers for adult-only conditions; the EU is revising that regulation to adopt a mechanism-of-action test. In practice the two levers, together with the ACCELERATE Paediatric Strategy Forums, are why paediatric plans now accompany most new ALK, MEK, BRAF, NTRK, RET, BCL2, CDK4/6 and ADC programmes, and why tovorafenib, dabrafenib-trametinib and selpercatinib reached children within a few years of adult data.

## Fields

- Kind: Term
- Last checked: 2026-09-10
- Also known as: Research to Accelerate Cures and Equity for Children Act; FDARA Title V section 504; PREA molecular target amendment
- Tags: nci-coverage; paediatric; regulatory

## Sources

- FDA: relevant paediatric molecular target list: https://www.fda.gov/about-fda/oncology-center-excellence/pediatric-oncology
- FDARA 2017 (Public Law 115-52): https://www.congress.gov/bill/115th-congress/house-bill/2430

## Connected records

- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [FDASIA 2012 and the origins of the expedited programmes](https://onco.cc/terms/fdasia-2012/), [Orphan drug](https://onco.cc/terms/orphan-drug/), [Orphan Drug Act 1983](https://onco.cc/terms/orphan-drug-act/), [Paediatric drug laws: BPCA and PREA](https://onco.cc/terms/bpca-prea/), [Regulation (EC) No 141/2000: EU orphan medicines](https://onco.cc/terms/eu-orphan-regulation/), [Regulation (EC) No 1901/2006: EU paediatric medicines](https://onco.cc/terms/eu-paediatric-regulation/)
- cancers: [Diffuse midline glioma, H3 K27-altered (including DIPG)](https://onco.cc/cancers/dipg-dmg/), [Inflammatory myofibroblastic tumour (IMT)](https://onco.cc/cancers/inflammatory-myofibroblastic-tumour/), [Neuroblastoma (paediatric)](https://onco.cc/cancers/neuroblastoma/), [Paediatric low-grade glioma](https://onco.cc/cancers/paediatric-low-grade-glioma/), [Rare cancers of childhood (NCI PDQ umbrella)](https://onco.cc/cancers/rare-childhood-cancers/)
- drugs: [Dabrafenib + trametinib](https://onco.cc/drugs/dabrafenib-trametinib/), [Larotrectinib](https://onco.cc/drugs/larotrectinib/), [Selpercatinib](https://onco.cc/drugs/selpercatinib/), [Tovorafenib](https://onco.cc/drugs/tovorafenib/)
- companies: [Children's Oncology Group (COG)](https://onco.cc/companies/childrens-oncology-group/), [Innovative Therapies for Children with Cancer (ITCC)](https://onco.cc/companies/itcc/)
- institutions: [ACCELERATE](https://onco.cc/institutions/accelerate-platform/), [European Medicines Agency](https://onco.cc/institutions/ema/), [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/)
- trials: [ACTION](https://onco.cc/trials/action-dmg/), [FIREFLY-1](https://onco.cc/trials/firefly-1/), [NCI-COG Pediatric MATCH (APEC1621)](https://onco.cc/trials/pediatric-match/), [TADPOLE (CDRB436G2201)](https://onco.cc/trials/tadpole/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [Rare and paediatric cancers without markets](https://onco.cc/bottlenecks/b-rare-cancers/)
- roadmaps: [Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first](https://onco.cc/roadmaps/paediatric-oncology-roadmap/)

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