The FDA has raised concerns over Amgen Inc's lung cancer drug, Lumakras, ahead of the Oncologic Drugs Advisory Committee meeting. The FDA staff reviewers suggested that the company's late-stage trial might not be considered 'adequate and well-controlled'. While Lumakras was approved by the FDA in May 2021, the recent findings imply the potential need for an additional confirmatory trial. Despite this, the commercial prospects for Lumakras might be mitigated by encouraging outcomes in colorectal cancer treatments and additional planned combination studies.