FDA declines to grant Amgen’s Lumakras full approval in lung cancer after negative advisory committee vote
The FDA rejected Amgen’s bid to convert Lumakras’ accelerated approval into a full approval in lung cancer, the biopharma company announced Tuesday morning, and has asked the drugmaker to conduct a new confirmatory study to keep the product on the market.
The news is expected after a panel of outside experts voted 10-2 at an FDA advisory committee meeting in October that the KRAS-targeted drug’s key data could not be reliably interpreted in a confirmatory study in non-small cell lung cancer.
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