NEW YORK: Advisers to the US 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 Lumakras for patients with a type of advanced lung cancer.
The drug was approved by the FDA in 2021 under an accelerated pathway, with confirmatory data a condition for gaining traditional approval.
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.
The panel’s decision was in line with an assessment from FDA staff reviewers, who suggested earlier this week that the trial data may be biased and may not be sufficient to confirm the benefits of Lumakras.
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.
Lumakras is approved to treat advanced lung cancer in patients with mutations of the KRAS gene whose disease has worsened after chemotherapy or other treatments.
The FDA, which generally follows the advice of its expert panels but is not bound to do so, is expected to make a decision on the Amgen drug by Dec. 24.
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