ACCELERATE Paediatric Strategy Forums: an advance for oncological drug development?

The landscape of anticancer drug development in children is changing with the implementation of a science-driven, mechanism-of-action-based approach that better addresses the unmet medical needs of children rather than being driven by the adult indication. This shift has been greatly facilitated by new legislation in Europe and the USA. The US Food and Drug Administration (FDA) Reauthorization Act of 2017, which incorporates the Research to Accelerate Cures and Equity for Children Act, is a landmark legislation in the transition to a mechanism-of-action-based approach in paediatric cancer.