USA – FDA issues draft guidance to foster oncology product development for pediatric populations

“When it comes to medical product innovation, children must always remain front-of-mind, particularly those with dire needs. It is important to deliver promising new therapies as quickly as possible, while still ensuring the utmost safety,” said Acting FDA Commissioner Adm. Brett P. Giroir, M.D.

Traditionally, drug development for pediatric cancers lagged, in part, because the requirements to study new cancer drugs in children have been based on whether the cancer occurs in children — and many adult cancers rarely occur in children. New, targeted oncology drugs being developed for adult cancers may prove effective in the treatment of some cancers occurring primarily in pediatric patients with similar molecular targets.

Thanks to amendments to the Federal Food, Drug, and Cosmetic Act made by the FDA Reauthorization Act of 2017, we have a new mechanism to require the evaluation of certain novel cancer medicines for potential pediatric treatment. Our new draft guidance addresses implementation of these amendments, which we anticipate will facilitate early pediatric assessment of certain targeted cancer drugs and accelerate the development of new, safe and effective therapies for pediatric patients. ”…