Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.
Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval.
The therapy faced an advisory committee meeting in October where a panel was asked to consider whether the primary endpoint for the phase 3 CodeBreak 200 trial could be reliably interpreted in Amgen’s study. The committee voted 10-2 against the measure, suggesting that they were unimpressed with Amgen’s trial design.
Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly what the FDA has done, with the request to flip the accelerated approval into a full approval rejected with a complete response letter, according to a December 26 news release.
Amgen will have until February 2028 to complete a new study confirming the clinical benefit of Lumakras.
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