The Food and Drug Administration has warned Amgen that a promotional video for its colorectal cancer therapy Vectibix is misleading because it emphasizes benefits while failing to disclose major safety risks and limits on who may be treated, the agency said Tuesday.
FDA cites missing safety information and patient limits
In a warning letter dated Aug. 12, the FDA said the video described Vectibix as an option for adults with a form of advanced colorectal cancer and noted that infusions can take about 60 minutes or less and do not require premedication. Regulators said the presentation contained no discussion of Vectibix’s boxed warning or other serious adverse events.
“By failing to adequately communicate the full indication for Vectibix and limitations of use associated with Vectibix, the video creates a misleading impression about the drug's FDA‑approved indication and use,” the FDA said.
The agency detailed hazards linked with the medicine, including severe skin reactions, potentially fatal infusion reactions, lung disease and kidney failure. The FDA also faulted the video for not explaining that use of Vectibix depends on specific tumor testing and that only certain patients are eligible under the approved indication.
FDA demands corrective steps and sets a response deadline
The FDA told Amgen to stop distributing the misleading material, submit a written response within 15 working days and propose communications to correct the record for the video's audience. The agency warned that failure to resolve the issues could prompt legal action, including product seizure or an injunction.
- Drug: Vectibix (panitumumab), marketed by Amgen for a subset of advanced colorectal cancers
- Concerns: absence of boxed warning mention and omission of serious adverse events
- Regulatory action: warning letter, requirement to propose corrective communications within 15 working days
The warning letter was reported by Reuters. Amgen did not immediately provide a public comment to Reuters about the FDA’s notice.
