(Reuters) -The U.S. Food and Drug Administration’s staff reviewers said on Tuesday that Amgen’s late-stage study may not provide enough evidence of effectiveness for its lung cancer drug, as the company pursues a traditional approval for the treatment.
The comments come ahead of a panel meeting of expert advisers to the health agency on Thursday.
Amgen’s drug, Lumakras, was approved by the U.S. FDA in 2021 under an accelerated pathway for advanced lung cancer patients with KRAS mutations after an initial treatment has failed or stopped working.
Staff reviewers added that the company’s late-stage trial may not be considered “adequate and well controlled”, according to briefing documents published on the agency’s website.
Amgen will also present data from its confirmatory late-stage trial at the meeting.
(Reporting by Bhanvi Satija and Pratik Jain in Bengaluru; Editing by Sherry Jacob-Phillips and Shounak Dasgupta)
