The age of paediatric melanoma used to be a theoretical discussion, but has become a real-life challenge due to arbitrary age limits decreed by regulatory authorities. Metastasised melanoma is today treated effectively with drug combinations. And young patients?
Thirteen European Medicines Agency (EMA) paediatric investigation plans (PIPs) and one Food and Drug Administration (FDA) “Written Request” demand monotherapy studies in paediatric melanoma.
Klaus Rose at Klausrose Consulting discusses the conundrum of paediatric trials and the ways forward.