Advisers to the U.S. Food and Drug Administration on Thursday found that data from a late-stage trial was not reliable enough to support traditional approval of Amgen's (AMGN.O) Lumakras for patients with a type of advanced lung cancer.
An Amgen sign is seen at the company's office in South San Francisco, California October 21, 2013. The biopharmaceutical company reports earnings on Tuesday. REUTERS/Robert Galbraith/File Photo
The FDA panel voted 10 to 2 that the main goal of the late-stage confirmatory study could not be relied upon to assess the benefits of the drug. They flagged several issues with the trial, including the way the study was conducted and loss of follow-up data from patients who withdrew consent.
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