Amgen stock dips after FDA reveals concerns about Lumakras study (update)
Iryna Drozd
Shares of Amgen (NASDAQ:AMGN) were down 2% in midday trading Tuesday after the FDA released briefing materials that questioned a key clinical study ahead of an advisory panel meeting for Amgenâs lung cancer drug Lumakras to discuss granting the product full regulatory approval.
The FDA released the briefing materials in preparation of the meeting, which is scheduled for Thursday. In one agency document, FDA staff reviewers commented that features of a study for Lumakras called CodeBreaK 200 âdid not appear consistent with an adequate and well-controlled trial.â
Lumakras is also known as sotorasib. The medication belongs to a class of drugs known as KRAS inhibitors.
Amgen is using results from CodeBreaK 200 to support full approval of Lumakras, which was granted accelerated approval in 2021 for the treatment of advanced or metastatic non-small cell lung cancer with KRAS G12C mutations. The company plans to present results from the study at the FDA meeting on Thursday.
While the FDA is not bound to the recommendations of its advisory panels, it generally follows them. 
Last week, shares of Mirati (MRTX) rallied amid news that it plans to present updated data later this month on its KRAS inhibitor lung cancer drug Krazati, which many view as a potential competitor to Lumakras. 
(Updates with information about Mirati KRAS inhibitor drug.)
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