US FDA In No Hurry To Withdraw Amgen’s Lumakras Despite Negative Adcomm Vote On Confirmatory Trial Results

 
• By Sue Sutter

ODAC votes 10-2 that the progression-free survival data in CodeBreaK 200 cannot be reliably interpreted due to various study conduct issues; agency assures the committee that it is not currently proposing withdrawal and that multiple regulatory pathways are available for sotorasib, one of two KRAS G12C inhibitors on the market under accelerated approval.

Balance beam
In a meeting filled with "statistical gymnastics," FDA's advisory committee said PFS results from CodeBreaK 200 could not be relied upon. • Source: Shutterstock

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