Barrons.com
FDA Wants Another Amgen Study on Lumakras
Amgen will need to run another confirmatory study to win full FDA approval of its lung-cancer drug Lumakras. Amgen says the FDA, which granted conditional approval to the drug in 2021, has turned away its application seeking full approval and called on the company to complete the additional study by February 2028. An FDA advisory panel in October raised issues with Amgen’s previous confirmatory study, citing problems with how the study was conducted, its small size and relatively minor extension of the time that patients lived without their cancers getting worse.