FDA Posts Lists of Molecular Targets for Pediatric Cancer

Federal Register notice: FDA’s Oncology Center of Excellence Pediatric Oncology Program has announced the creation of a list of molecular targets that have been determined to be substantially relevant to the growth or progression of a pediatric cancer and a list of molecular targets of new cancer drugs and biological products in development for which requirements for studies in pediatric cancers would be automatically waived. The first list includes molecular targets for which prevailing evidence or a scientific rationale exists to determine their potential relevance to the growth or progression of one or more pediatric cancers. The second list details those targets that are unlikely to be associated with the growth or progression of pediatric cancers and therefore cause a waiver of statutory requirements for early pediatric evaluation. To view the notice, click here.