The US Food and Drug Administration (FDA) has issued a warning letter to Amgen over a promotional video for Vectibix (panitumumab), a treatment for a type of metastatic colorectal cancer. The letter, dated 12 August 2026 and published on 27 October, says the video was "false or misleading". Amgen says the file reviewed was submitted in error.
The letter was sent by the FDA's Office of Prescription Drug Promotion (OPDP), the unit that reviews advertising and promotional material for prescription medicines in the United States. According to the letter, the video presented benefits of Vectibix without any risk information and did not set out the drug's full approved indication or its limitations of use. The letter concerns promotion in the US only.
- Issuer: FDA Office of Prescription Drug Promotion, letter dated 12 August 2026, posted on the FDA website on 27 October 2026 (reference MARCS-CMS 739641).
- Material: a promotional video for Vectibix (code USA-954-81023) that Amgen submitted to the FDA on Form FDA 2253.
- FDA's concerns: the video, the letter says, "entirely omits risk information" and does not communicate the full indication and limitations of use.
- Requested action: a written response within 15 working days of receipt and a plan for corrective communications.
- Amgen's position: an incorrect video file was "inadvertently submitted" to the FDA and "was never publicly disseminated", according to a company spokesperson quoted by Reuters.
1. What the FDA letter says
The warning letter is addressed to Amgen chairman and chief executive Robert Bradway and signed by Kathleen Klemm, director of OPDP's Division of Advertising and Promotion Review 1. It states that OPDP reviewed a video for Vectibix submitted by Amgen and "determined that the video is false or misleading". On that basis, the letter says, the video misbrands Vectibix under the Federal Food, Drug, and Cosmetic Act.
The letter raises two concerns. The first is the presentation of risk. According to the FDA, the video appears under the heading "For adult patients with wild-type RAS* mCRC" and includes the claims "60 minutes or less of infusion time" and "No premedication", shown alongside a crossed-out intravenous bag, together with imagery of a colon. The FDA says the video "entirely omits risk information" and that this creates "a misleading impression about the drug's safety".
The letter notes that Vectibix carries a boxed warning, the strongest form of US label warning, for dermatologic (skin) toxicity. It also lists other serious risks named in the prescribing information, including infusion reactions, pulmonary fibrosis and interstitial lung disease.
The second concern is the omission of what the FDA calls material facts about the approved use. In the US, Vectibix is indicated for adults with wild-type RAS metastatic colorectal cancer, either first line in combination with FOLFOX chemotherapy or as monotherapy after prior chemotherapy has stopped working. According to the letter, the video "does not specify that Vectibix is indicated in specific regimens based on its line in therapy" and does not disclose its limitations of use, including that it is not indicated where RAS mutation status is unknown.
| Item | Detail |
|---|---|
| Issuing office | Office of Prescription Drug Promotion, Center for Drug Evaluation and Research |
| Product | Vectibix (panitumumab) injection for intravenous use, BLA 125147 |
| Material reviewed | Promotional video, code USA-954-81023 |
| Concerns cited | False or misleading risk presentation; omission of material facts on indication and limitations of use |
| Response deadline | 15 working days from receipt of the letter |
| Audience of the video | Not disclosed in the letter |
2. What the FDA asked Amgen to do
The letter asks Amgen to "take immediate action to address any violations", giving as an example ceasing promotional communications that are misleading in the ways described. It asks for a written response within 15 working days of receipt that lists any other Vectibix promotional materials containing similar representations and explains a plan to discontinue them.
The FDA also requests a plan for corrective communications to reach the audiences that received the original video, using, where possible, the same media and a similar duration and frequency. The letter states that companies may instead set out their reasoning if they believe their products are not in violation. As is standard wording in such letters, it also notes that failure to address violations "may result in legal action without further notice". The letter does not say whether any further step is planned, and the FDA has not published Amgen's reply.
3. Amgen's response
Amgen says the video the FDA reviewed did not reach the public. A company spokesperson told Reuters that "an incorrect video file for a Vectibix advertisement was inadvertently submitted to FDA" and that this file "was never publicly disseminated". The spokesperson said "the Vectibix advertisement that was publicly disseminated included the appropriate important safety information" and that the company "has submitted the correct file to the FDA".
The FDA letter itself does not address that explanation, since it was written in August and refers only to the material Amgen submitted. Priya Life Science has not seen the version of the advertisement that Amgen says was used publicly.
4. Context: the FDA's push on drug promotion
OPDP warning letters are one of the tools the FDA uses to police how prescription medicines are marketed in the United States. Companies must submit promotional materials to the agency on Form FDA 2253 when they are first used, and OPDP can then question claims it considers misleading.
On 9 September 2025 the US Department of Health and Human Services and the FDA announced a campaign against misleading drug advertising, saying the FDA was sending "thousands of letters" to companies and about 100 cease-and-desist letters. Readers can learn more about how these letters work in our guide to FDA warning letters and what they mean for Irish sites. A different type of FDA warning letter, concerning manufacturing data rather than promotion, was covered in our report on Sanofi's Waterford site.
5. The Irish and European picture
Amgen is a significant employer in Ireland. According to Amgen Ireland, the company employs 1,250 people across three sites: a commercial office in Santry, a manufacturing plant in Dún Laoghaire, Co Dublin, and a Waterford plant acquired with Horizon Therapeutics in 2023. Amgen says the 32-acre Dún Laoghaire facility, bought in 2011, specialises in formulation, aseptic drug product filling, lyophilisation and packaging, exports to more than 50 countries and is its largest manufacturing site outside the US. Amgen does not state on that page which products are made in Dún Laoghaire, and we have not seen any official source linking Vectibix production to Ireland. More on the company is on our Amgen Ireland page.
In the European Union, Vectibix has been authorised since 3 December 2007, according to the European Medicines Agency. The marketing authorisation holder is Amgen Europe B.V. The EU indication covers adults with wild-type RAS metastatic colorectal cancer in first line with FOLFOX or FOLFIRI, in second line with FOLFIRI, and as monotherapy after earlier chemotherapy. Promotion of prescription medicines in Ireland is governed by EU and Irish rules overseen by the HPRA, not by the FDA, and the warning letter makes no reference to activity outside the US.
In Ireland, the HSE's National Cancer Control Programme (NCCP) publishes three national regimens containing panitumumab: monotherapy, panitumumab with FOLFIRI, and panitumumab with modified FOLFOX-6. All three are restricted to wild-type RAS disease confirmed by a validated test, and the monotherapy regimen lists unknown RAS status as an exclusion. The FOLFOX-6 regimen records hospital reimbursement status. Current studies are listed on our panitumumab page.
Frequently Asked Questions
Does the warning letter affect patients receiving Vectibix?
The letter concerns a promotional video, not the safety, quality or approval of the medicine itself. It does not withdraw or change the drug's approval. Patients with questions about their treatment should speak to their oncology team.
Does the letter apply in Ireland or the EU?
No. It was issued by the US FDA about promotion in the United States. Advertising of medicines in Ireland falls under EU and Irish rules overseen by the HPRA.
What happens next?
The FDA asked Amgen to respond within 15 working days of receiving the letter in August. Neither the FDA nor Amgen has published that response, and the outcome has not been disclosed.
Outlook
The key open question is how the FDA treats Amgen's explanation that the wrong file was submitted and that the advertisement shown publicly carried safety information. Any further correspondence the FDA chooses to publish, such as a close-out letter, would appear in its warning letters database. Until then, the letter and Amgen's statement are the only public accounts of the matter.
Sources
- US Food and Drug Administration, Warning Letter to Amgen Inc., MARCS-CMS 739641, 12 August 2026 (posted 27 October 2026)
- US Food and Drug Administration, FDA Launches Crackdown on Deceptive Drug Advertising, 9 September 2025
- European Medicines Agency, Vectibix EPAR, accessed 2 November 2026
- HSE National Cancer Control Programme, Gastrointestinal SACT regimens (regimens 00225, 00447, 00448), accessed 2 November 2026
- Amgen Ireland, About Amgen, accessed 2 November 2026
- Reuters via WSAU, US FDA warns Amgen over cancer drug promotional video, 27 October 2026
- Fierce Pharma, Amgen hit with FDA warning letter for 'misleading' Vectibix promotion, October 2026
Cover image: Amgen headquarters, Thousand Oaks, California, Coolcaesar, CC BY-SA 3.0, via Wikimedia Commons. The photo shows the US headquarters, not an Irish site.
