FDA AdCom Gives Thumbs Down To Late-Stage Data For Amgen's Lumakras In Advanced Form Of Lung Cancer (UPDATED)

Editor's note: The headline of this story has been updated to make clearer the FDA vote is on late-stage Lumakras data. 

FDA advisers concluded that the data from a late-stage trial lacks the requisite reliability to endorse the traditional approval of Amgen Inc's AMGN Lumakras for patients afflicted with an advanced form of lung cancer.

During the meeting, the FDA's expert advisers voted 10-2, expressing doubts about relying on the primary goal of the late-stage confirmatory study to assess the drug's benefits.

The drug had initially received FDA approval in 2021 through an accelerated pathway, contingent on confirmatory trial data.

The primary objective of the confirmatory study was to determine progression-free survival (PFS), measuring the duration before the disease's progression. However, the FDA raised questions regarding the trial's methodology.

The confirmatory study data revealed that Lumakras reduced the risk of disease progression in patients with advanced lung cancer by 34% compared to chemotherapy. 

While there was no significant difference in overall survival, Amgen clarified that the study was not designed to demonstrate a survival advantage.

Lumakras is now awaiting a decision from the FDA on traditional approval by Dec. 24.

Amgen's advisory committee occurs at an intriguing juncture for KRAS inhibitors such as Lumakras, coinciding with the emergence of Mirati Therapeutics Inc's MRTX competitor, Krazati.

Price Action: MRTX shares closed at $62.38 on Thursday.