Amgen has been handed an FDA warning letter over a video promoting its cancer drug Vectibix, but the company said that the issues stemmed from an inadvertent submission and was not made available publicly.
Vectibix first won FDA approval back in 2006 for certain patients with advanced colorectal cancer. It has since picked up additional approvals for the disease, most recently in 2025 as a combination treatment with Amgen’s cancer drug Lumakras for patients with KRAS G12C-mutated metastatic colorectal cancer who had previously received chemotherapy.
Vectibix carries a boxed warning for dermatologic toxicity, along with warnings about several other serious and potentially fatal risks, including infusion reactions, pulmonary fibrosis and interstitial lung disease.
But the FDA said a promotional video submitted by Amgen “entirely omits risk information.”
The agency said the video is “misleading” because it highlights the benefits of Vectibix but “fails to communicate any risk information.”
That omission “creates a misleading impression about the drug’s safety,” the regulator said in its warning letter, adding that “this omission is especially problematic from a public health perspective given the serious and potentially fatal risks associated with the drug.”
The FDA also said that while the Amgen video suggests that Vectibix can be used to treat wild-type RAS metastatic colorectal cancer (mCRC) generally, it “does not specify that Vectibix is indicated in specific regimens based on its line in therapy.”
The video also failed to adequately communicate Vectibix's limitations of use, including restrictions involving patients with RAS-mutant mCRC or unknown RAS mutation status. As a result, the video “creates a misleading impression about the drug’s FDA-approved indication and use,” the FDA said.
The warning letter, issued by the FDA's Office of Prescription Drug Promotion, was dated Aug. 12 but only became public Oct. 27. Amgen was given 15 working days from receipt of the letter to respond to the agency's concerns, including outlining plans to address the alleged violations.
An Amgen spokesperson told Fierce: “An incorrect video file for a Vectibix advertisement was inadvertently submitted to the FDA that did not contain the required risk information, but the file was never publicly disseminated.
“Amgen considers the appropriate communication of risk information to be of utmost importance in its promotional materials, and we take all concerns very seriously. The Vectibix advertisement that was publicly disseminated included the appropriate Important Safety Information, and we have submitted the correct file to the FDA.”