FDA Warns Amgen Over Misleading Vectibix Video

The FDA's Office of Prescription Drug Promotion has issued a warning letter to Amgen over a promotional video for Vectibix (panitumumab), an approved intravenous treatment for a subset of metastatic colorectal cancer. According to the FDA warning letter, the video highlighted convenience claims, including a short infusion time, no premedication required, and colon imagery, while leaving out any risk information at all.

That omission matters because Vectibix carries a boxed warning for dermatologic toxicity, along with other serious risks such as infusion reactions, pulmonary fibrosis, and interstitial lung disease. The letter also notes the video failed to communicate the drug's full approved indication and its limitations, including that it is meant only for patients whose tumors are confirmed wild type for RAS mutations through an approved test.

This case is a reminder of how strict FDA rules are around marketing an already approved therapy, not a signal about new research. Vectibix itself is not under study here; the issue is how its benefits and risks were presented to clinicians and the public. The agency has asked Amgen to stop using the video and address the violations.

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