(Reuters) – 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 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.
(Reporting by Pratik Jain and Bhanvi Satija in Begaluru; Editing by Bill Berkrot)
