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This is a Quantitative Study study.

September 28, 2025Frontiers in MedicineOpen Access

Scientific and regulatory progress in advancing paediatric oncology drug development in the EU and in the US

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This research demonstrates increased paediatric product approvals in oncology, highlighting EU and US regulatory gaps.

In the 2018–2024 period, more paediatric oncology products have been approved in both the EU and US, suggesting progress in drug development.
The RACE Act mandates paediatric indications based on drug mechanism of action, indicating a shift towards targeting childhood cancers.
Linear regression models revealed growing approvals for solid tumours, with immunotherapeutic agents leading advancements over traditional chemotherapies.
Despite progress, significant gaps remain between the EU and US regulatory systems for paediatric oncology, emphasizing the need for targeted initiatives.

Reggiardo et al. (2025) studied this question.

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