Friends of Cancer Research will host a meeting today to discuss the types of drugs that would likely need to be studied in pediatric cancer patients under a provision in last year’s FDA Reauthorization Act, S. 934 (115). While drug companies with new applications have long been required to study those medicines in children, the law hasn’t been very successful because adults and children tend to get different cancers. The new law requires drugmakers to study medicines in children if the adult version is directed at a molecular target relevant to a pediatric cancer. Orphan cancer drugs are exempt from the requirement.
Today’s meeting comes as FDA develops the molecular targets relevant to the growth of pediatric cancers that may trigger the new study requirements. Malcolm Smith of the National Cancer Institute and FDA’s Gregory Reaman will give presentations. Read Friends of Cancer Research’s discussion paper here.