RACE for Children Act
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.
Overview
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.
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