The US Food and Drug Administration is questioning whether the confirmatory trial for Amgen, Inc.’s Lumakras (sotorasib) was sufficiently adequate and well-controlled to verify the accelerated approval drug’s clinical benefit in non-small cell lung cancer.
Amgen’s Lumakras: FDA Flags ‘Marginal’ Efficacy Results, Potential Systemic Bias In Lung Cancer Trial
Company seeks conversion from accelerated to regular approval for the first KRAS G12C inhibitor on the market, but the agency is asking its Oncologic Drugs Advisory Committee whether the progression-free survival primary endpoint in the CodeBreaK 200 confirmatory trial can be reliably interpreted.
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