The FDA has warned Amgen that a promotional video for its colorectal cancer drug Vectibix (panitumumab) is false or misleading because it omitted risk information and the drug’s limitations of use, according to an Aug. 12 warning letter posted to the agency’s website.
The agency’s Office of Prescription Drug Promotion said the video, which Amgen submitted to the FDA, highlights benefits such as an infusion time of 60 minutes or less and “no premedication,” shown alongside an image of a crossed-out IV bag, without any risk information. Vectibix carries a boxed warning for dermatologic toxicity, along with warnings for infusion reactions, pulmonary fibrosis and interstitial lung disease, among other serious and potentially fatal risks, the FDA noted. The agency said omitting the risks was “especially problematic” given those dangers.
The FDA also said the video fails to disclose the drug’s full indication. Vectibix is approved for adults with wild-type RAS metastatic colorectal cancer as first-line therapy with FOLFOX or as monotherapy after progression on prior chemotherapy. The video suggests use for wild-type RAS disease generally and does not say the drug is not indicated for RAS-mutant disease, except with sotorasib in KRAS G12C-mutated disease, or when RAS status is unknown.
The agency asked Amgen to stop the misleading communications and respond in writing within 15 working days, with a list of other promotional materials making similar claims, a plan to discontinue them and a plan for corrective messaging to the audiences that received the video. The FDA said failure to address the violations adequately could lead to legal action without further notice, including seizure and injunction.
In a statement to Becker’s, an Amgen spokesperson said an incorrect video file for a Vectibix advertisement, one that didn’t contain the required risk information, was inadvertently submitted to the FDA but was never publicly disseminated. The advertisement that was publicly disseminated included the appropriate important safety information, and Amgen has submitted the correct file to the FDA. The company considers communicating risk information “of utmost importance in its promotional materials,” the spokesperson said.
The letter comes amid increased FDA enforcement against misleading drug promotion that began in September 2025. The agency said in March it had sent thousands of letters to drugmakers and telehealth firms over the preceding six months, more than it sent in the entire decade before.
The letter also adds to a separate dispute between Amgen and the FDA over its rare disease drug Tavneos (avacopan). In April, the FDA’s drug center proposed withdrawing approval of the drug, saying unblinded study personnel manipulated results of its pivotal trial and that the original analysis was not disclosed to the agency. The FDA also linked the drug to 76 postmarketing cases of drug-induced liver injury.
Amgen declined the FDA’s January request to withdraw the drug, requested a hearing and submitted an independent re-adjudication of the trial data by the Duke Clinical Research Institute. The company says it strongly disagrees with the proposal, and Tavneos remains on the U.S. market while the process continues.
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