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# FDA Warns Amgen Over Misleading Vectibix Promotional Video
- URL: https://www.fdaweb.com/fda-warns-amgen-over-misleading-vectibix-promotional-video/
- Published: 2026-10-27T23:13:00.000Z
- Updated: 2026-10-27T23:14:41.000Z
- Author: David McFarland
- Tags: Drugs, enforcement

FDA has issued a Warning Letter to Amgen over a promotional video for its colorectal cancer drug Vectibix (panitumumab) because it omitted all safety information and failed to disclose important limitations on the drug’s approved uses. In the just-posted [8/12 Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amgen-inc-739641-08122026?utm%5Fsource=chatgpt.com), CDER’s Office of Prescription Drug Promotion (OPDP) said the video was false or misleading and misbranded Vectibix in violation of the Federal Food, Drug, and Cosmetic Act.

The video, submitted to FDA under Form 2253, promoted Vectibix for patients with wild-type RAS metastatic colorectal cancer, but it entirely omitted information about the drug’s risks, including a Boxed Warning for dermatologic toxicity and other potentially fatal adverse reactions such as infusion reactions, pulmonary fibrosis and interstitial lung disease, the letter said.

"This omission is especially problematic from a public health perspective given the serious and potentially fatal risks associated with the drug," OPDP said.

FDA also cited the video’s failure to adequately describe the drug’s approved indications and limitations of use. According to OPDP, the video suggested Vectibix could be used generally to treat wild-type RAS metastatic colorectal cancer without explaining the treatment-specific restrictions. It also failed to disclose limitations involving RAS-mutant tumors and patients whose RAS mutation status is unknown.

The Amgen action is among a relatively small number of Warning Letters issued in FDA's drug promotion enforcement program, which more frequently relies on untitled letters to address allegedly misleading advertising. Other companies receiving warning letters in 2025 and 2026 include Eli Lilly, Novo Nordisk, ImmunityBio, Sprout Pharmaceuticals and Sarfez Pharmaceuticals (*see listing below*).

**2026 OPDP Warning Letters**

- Aug. 12 — Amgen (Vectibix): [FDA warning letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amgen-inc-739641-08122026?utm%5Fsource=chatgpt.com)
- March 13 — ImmunityBio (Anktiva): [FDA warning letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/immunitybio-inc-725468-03132026?utm%5Fsource=chatgpt.com)

**2025 OPDP Warning Letters**

- Sept. 9 — Novo Nordisk (Wegovy, Ozempic, Victoza): [FDA warning letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novo-nordisk-inc-716495-09092025?utm%5Fsource=chatgpt.com)
- Sept. 9 — Eli Lilly (Zepbound, Mounjaro): [FDA warning letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eli-lilly-and-company-716485-09092025?utm%5Fsource=chatgpt.com)
- May 29 — Sprout Pharmaceuticals (Addyi): [FDA warning letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sprout-pharmaceuticals-inc-709942-05292025?utm%5Fsource=chatgpt.com)
- April 25 — Sarfez Pharmaceuticals (Soaanz): [FDA warning letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sarfez-pharmaceuticals-inc-708901-04252025?utm%5Fsource=chatgpt.com)