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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

The US Food and Drug Administration appears in no hurry to try to remove Amgen, Inc.’s accelerated approval lung cancer drug Lumakras (sotorasib) from the market despite an advisory committee’s conclusion that the progression-free survival endpoint in the CodeBreaK 200 confirmatory trial could not be reliably interpreted.

On 5 October, the Oncologic Drugs Advisory Committee voted 10-2 that the primary endpoint in CodeBreaK 200, PFS by blinded independent central review (BICR), could not be reliably interpreted due to a

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