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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.
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.
Showing the molecule this term concerns: Tovorafenib.
Shares Rare cancers of childhood (NCI PDQ umbrella), Children's Oncology Group (COG), Neuroblastoma (paediatric) and the tag paediatric.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Children's Oncology Group (COG), Neuroblastoma (paediatric) and the tag paediatric.
Shares Rare and paediatric cancers without markets and the tag paediatric.
Shares Inflammatory myofibroblastic tumour (IMT), Rare cancers of childhood (NCI PDQ umbrella), Children's Oncology Group (COG), Rare and paediatric cancers without markets and the tag paediatric.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Children's Oncology Group (COG), Neuroblastoma (paediatric) and the tag paediatric.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Children's Oncology Group (COG), Neuroblastoma (paediatric) and the tag paediatric.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Children's Oncology Group (COG), Rare and paediatric cancers without markets and the tag paediatric.
Shares Dabrafenib + trametinib, Paediatric low-grade glioma, Children's Oncology Group (COG), Rare and paediatric cancers without markets and the tag paediatric.