The U.S. Food and Drug Administration has sent Amgen a warning letter faulting a promotional video for the cancer drug Vectibix that, according to regulators, omitted all safety information. Amgen says the video was an incorrect file submitted to the agency by mistake and was never shown to the public.
What the FDA found
The FDA's Office of Prescription Drug Promotion said the video touted Vectibix's benefits while "entirely" leaving out risk information, calling the material "misleading" because it created a false impression of the drug's safety profile. Vectibix carries a boxed warning for dermatologic toxicity and additional warnings for infusion reactions, pulmonary fibrosis and interstitial lung disease - risks the agency said are serious enough that omitting them from promotional content is "especially problematic from a public health perspective."
Regulators also said the video implied Vectibix could be used broadly for wild-type RAS metastatic colorectal cancer without specifying that its approval depends on the patient's line of therapy, and without noting limitations for patients with RAS-mutant disease or unknown RAS mutation status. The FDA said this created a misleading impression of the drug's approved use.
Amgen's response
An Amgen spokesperson told Fierce that an incorrect video file lacking the required risk information was "inadvertently submitted" to the FDA, but that the file "was never publicly disseminated." The company said the version of the advertisement that actually reached the public included the appropriate Important Safety Information, and that it has since submitted the correct file to the agency. Amgen said it treats accurate risk communication in promotional materials as a top priority.
Timeline and next steps
The warning letter was dated Aug. 12, 2025, but was not made public until Oct. 27. Under standard FDA procedure, Amgen had 15 working days from receipt of the letter to respond to the agency's concerns, including describing how it plans to address the alleged violations.
Background on Vectibix
Vectibix first received FDA approval in 2006 for certain patients with advanced colorectal cancer and has since gained additional approvals, most recently in 2025 as part of a combination regimen with Amgen's drug Lumakras for patients with KRAS G12C-mutated metastatic colorectal cancer who had already undergone chemotherapy. The case underscores the FDA's ongoing scrutiny of how pharmaceutical companies balance drug benefits and risks in promotional materials submitted to the agency.