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Pediatric Cancer: US FDA Will Take ‘Rational’ Approach To Requiring Combination Studies

 
• By Sue Sutter

Agency urged to prioritize studies based on strength of preclinical and adult data, and good mechanistic understanding of how multiple therapies are expected to work together; new pediatric study requirements for molecularly targeted agents take effect in August 2020.

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Figuring out how different agents fit together to treat pediatric cancers will require prioritization. • Source: Shutterstock

The US Food and Drug Administration intends to take a measured approach to deciding what combinations of therapies should be investigated when new pediatric cancer study requirements take effect in August 2020.

“I think we want to be as rational and as clinically and scientifically appropriate in the decision-making about when to proceed, how to proceed with early evaluation of novel agents and early evaluation of novel agents that are going to require combinations with something else,” the FDA’s Gregory

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