FDA Warns Amgen Over Vectibix Video, Gives It 15 Business Days to Address Violations
Key Facts
The U.S. Food and Drug Administration warned Amgen over a promotional video for Vectibix, saying it highlighted the treatment’s benefits without adequately disclosing its serious risks and patient restrictions. Reuters reported that the letter was dated August 12, 2026, and said the agency asked Amgen to stop the misleading promotional materials and respond in writing within 15 business days of receiving the request. The FDA’s objection centered on the lack of information the public needs to understand the drug’s risks and which patients can use it. The agency also asked Amgen to propose corrective communications reaching the video’s audience. It warned that failure to address the violations could lead to legal action, including product seizure or an injunction.
The video, according to Reuters, focused on practical aspects of treatment, saying the infusion could take 60 minutes or less and patients did not need premedication before receiving it. But the FDA said the presentation did not include information about risks, despite a prominent warning on Vectibix about severe dermatologic reactions. Other risks cited by the agency include potentially fatal infusion reactions, lung disease, kidney failure and other serious side effects. The objection therefore concerned how the benefits were presented without safety information, not a claim that the drug’s efficacy itself was misleading. The FDA said the omission created a misleading impression of the drug’s approved indication and use.
The agency also objected that the video did not clarify which patient groups were eligible for treatment, including restrictions tied to tumor testing. The official label specifies Vectibix use in patients with metastatic colorectal cancer whose RAS status is wild-type, as determined by an approved test. The label does not recommend its use when RAS status is unknown, and restricts its use in RAS-mutant disease to specific cases, including administration with sotorasib for patients with KRAS G12C. That makes tumor status and test results part of the use restrictions that should appear in promotional messages. The FDA said omitting the full indication and use restrictions left viewers with an inaccurate understanding of the approved use.
The official label explains why skin risks feature in the warning: skin toxicity was reported in 90% of patients who received Vectibix as monotherapy, and it was severe in 15% of them. Those rates apply to monotherapy, as stated in the label, while the FDA described the warning about severe dermatologic reactions as prominent. This context sits alongside the other risks cited by the agency, including potentially fatal infusion reactions, lung disease and kidney failure. The FDA therefore asked Amgen to address the promotional materials and communicate corrections to the audience that saw the video. The letter, according to details reported by Reuters, did not say the drug had been withdrawn or that a seizure had already taken place; seizure or an injunction were cited as possibilities conditional on failure to address the problems.
The drug also has an approved use in a different treatment combination: on January 16, 2025, the FDA approved panitumumab, the active ingredient in Vectibix, with sotorasib to treat adults with metastatic colorectal cancer carrying a KRAS G12C mutation after specified prior chemotherapy. The approval was based on the CodeBreaK 300 trial, in which median progression-free survival was 5.6 months with the higher dose of sotorasib plus panitumumab, compared with two months with standard care. The trial’s final overall survival analysis was not statistically significant, according to approval information. This specific use underscores the importance of tying treatment messages to disease characteristics, testing and accompanying therapy. The FDA’s objection to the video concerned omissions about risks and restrictions, not revocation of approval for this use.
In trading, Amgen shares closed at $444.63 on October 26, 2026, according to EL7 data. This is the closing price available for that session; the data provided do not include a daily range or a change attributed to the warning. It places the stock in a time context before Reuters published details of the action, without implying a specific market impact from the letter. The available facts do not include subsequent share-price movements linked to the news. The regulatory response and the deadline for the company therefore remain the confirmed focus of the case.
In the next item on the calendar, the Federal Reserve’s Federal Open Market Committee meets on October 27 and 28, 2026, and its calendar lists a press conference on October 28. The calendar sets the meeting and press conference dates, but by itself does not establish the time the rate decision will be released. In the Amgen case, the required steps are to stop the materials at issue and submit a written response within 15 business days of receiving the request, along with a proposal for corrective communications to the video’s audience. The FDA linked the possibility of legal escalation to failure to address the violations. This remains a warning and a required action for the company, not an announcement that a seizure has been carried out or an injunction issued.