Make paediatric combination studies part of every relevant adult cancer drug approval
Children's cancers are treated with combinations, but companies study new drugs in children one at a time. Approvals should require the combination study children actually need.
The US RACE for Children Act requires paediatric evaluation of molecularly targeted adult cancer drugs, but permits single-agent studies that rarely lead to use, because paediatric standards of care are multi-drug backbones. Requiring the paediatric plan to include a combination with the relevant backbone, designed with cooperative groups, would produce actionable evidence.
- Too many combinations to test · There are thousands of possible drug pairs and sequences. Trials can test a few dozen a year.
- Rare and paediatric cancers without markets · Taken together rare cancers are a fifth of all cancers, but each one alone is too small for a company to invest in.
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