US WorldMeds’ Eflornithine Gets US FDA Panel Nod For Pediatric Neuroblastoma

 
• By Sue Sutter

In 14-6 vote, advisory committee said use of external control comparison to contextualize single-arm trial data demonstrated efficacy and reliance on preclinical data as confirmatory evidence was justified.  

Boy looking out window
ODAC looked outside to an external control group for a demonstration of DFMO's efficacy in pediatric neuroblastoma. • Source: Shutterstock

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