OnCo
ideasIdea

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.

Hypothesis
Drugs whose paediatric plans include a backbone combination will reach paediatric labelling or guideline inclusion at least twice as often within seven years as drugs studied as single agents.
Rationale
Nearly every paediatric oncology advance came from adding an agent to an existing backbone in a cooperative-group trial, not from monotherapy.
What would test it
Compare paediatric labelling outcomes for agents studied in combination versus monotherapy under current paediatric plans, then pilot the requirement with two new agents.
Maturity
speculative
Who has to act
regulator
Cost to try
Medium ($1M to $50M)
Years to first evidence
5
Bottlenecks it attacks

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