FDA lists 200 cancer targets that could require pediatric trials

In a move to spur development of drugs for pediatric populations and require more studies of pediatric cancers, FDA published Tuesday a list of 200 molecular targets that could trigger a requirement to conduct pediatric clinical studies. The agency can choose to mandate pediatric trials for compounds against a listed target even if the compound has Orphan Drug designation for the pediatric population, or if the adult indication does not occur in children.

The agency said the 200 targets are deemed "substantially relevant to the growth and progression of pediatric cancer." FDA developed the list to fulfill a requirement under the FDA Reauthorization Act of 2017 (FDARA)...