The FDA warned Amgen that a submitted Vectibix ad was misleading because it omitted risk information and limitations on the cancer drug’s approved use. Amgen said the submission was an incorrect draft that was never released publicly and that it has submitted the correct advertisement for FDA review.
Key Takeaways
- The FDA’s warning letter was dated August 12, 2026; Amgen’s account of the submission was reported on October 28.
- The agency requested a written response within 15 working days of Amgen’s receipt of the letter.
Why the Vectibix ad drew a warning
The FDA warning letter says the video described Vectibix’s benefits but omitted all risk information. The agency said this created a misleading impression of the drug’s safety. Vectibix, also known as panitumumab, is used to treat certain patients with metastatic colorectal cancer.
The FDA noted that Vectibix carries a boxed warning for dermatologic toxicity and has other serious, potentially fatal risks, including infusion reactions and lung disease.
The agency also said the video did not fully explain the drug’s approved indication or its limitations of use. For example, the letter says Vectibix is not indicated for metastatic colorectal cancer when the patient’s RAS mutation status is unknown.
Amgen’s response and the FDA’s request
Amgen said the version submitted to the FDA was an incorrect draft and was never publicly released. The company said the advertisement distributed publicly contained the necessary safety information and that it had submitted the correct promotional material for FDA review.
The FDA asked Amgen to address its concerns, identify other promotional communications containing similar representations and provide a plan for corrective communications. The letter warned that failure to adequately address violations could result in legal action.
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