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Animal Models: Adcomm Exposes Internal Rift In How FDA Defines ‘Translational’ For Purposes Of Confirmatory Evidence

 
• By Sue Sutter

FDA review staff consider the animal models used in development of US WorldMeds’ eflornithine for neuroblastoma to be translational to humans, even though this does not align with the definition in a September 2023 draft guidance on types of confirmatory evidence.

Mouse in lab
The translatability of mouse models to humans was critical to ODAC's view on the acceptance of such data as confirmatory evidence. • Source: Shutterstock

The recent advisory committee review of US WorldMeds, LLC’s eflornithine (DFMO) in high-risk neuroblastoma exposed an apparent difference of opinion between US FDA reviewers and a recently issued draft guidance on the use of animal model data for confirmatory evidence.

US WorldMeds’ new drug application rests on an externally controlled trial, with confirmatory evidence primarily in the form of nonclinical in vitro and animal model data. However, nonclinical data are...

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