Amgen's late-stage data for lung cancer drug 'not adequate' - FDA staff

 The comments come ahead of a panel meeting of expert advisers to the U.S. health agency, who will vote on the reliability of the data 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 failed or stopped working. The study was required by the U.S. regulators as a condition of accelerated approval for the drug.

Staff reviewers said the company's late-stage trial may not be considered "adequate and well-controlled", according to briefing documents published on the agency's website.

High censorship and the absence of a follow-up with patients who withdrew consent, among other issues with the study, may have impacted the extent of benefit Lumakras provided, compared with chemotherapy, the FDA staff said.

Data from the confirmatory study showed Lumakras reduced the risk of disease progression in patients with advanced lung cancer by 34%, compared with chemotherapy in a clinical trial.

There was no significant difference in overall survival between the two treatments in the study, and Amgen has said the trial was not designed to detect a survival difference.

Amgen's drug targets a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers, the most common form of the disease, and less frequently in some other solid tumors.

Lumakras bought in sales of $285 million in 2022.

The U.S. health regulator usually follows the advice of its panel, but is not bound to do so. The agency is expected to make a decision on the drug by Dec. 24.

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