FDA Posts Lists of Pediatric Cancer Drug Targets

October 23, 2018

The FDA’s Oncology Center of Excellence posted two new lists of molecular targets for pediatric study plans for anti-cancer drugs.

The first list identifies molecular targets that are likely to drive growth or progression of at least one form of pediatric cancer, while the other identifies targets for currently in-development drugs that would be exempt from pediatric cancer study requirements.

The agency issued the lists as part of its obligations under the FDA Reauthorization Act of 2017 (FDARA).  Until the passage of FDARA, section 505B of the Food, Drug and Cosmetic Act “has not typically been a useful mechanism to require the development of drugs for pediatric cancers since most of the oncology drugs approved for adults are used to treat cancers that are very rarely or never occur in children,” the agency said.

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