FDA Says Amgen's Vectibix Video Pitched Speed And Skipped Every Risk
The agency's drug-promotion office wants a written reply within 15 working days to a warning letter over a colorectal cancer video.
The FDA told Amgen that a promotional video for its colorectal cancer drug Vectibix is false or misleading because it entirely omits risk information and the drug's limits of use. The agency made the warning letter public on Tuesday; it sent the letter to Amgen on Aug. 12.
Benefits shown, risks left out
The letter, addressed to Amgen chairman and CEO Robert Bradway, comes from the FDA's Office of Prescription Drug Promotion. It says the video misbrands Vectibix (panitumumab) under the Federal Food, Drug, and Cosmetic Act.
Under a header for adult patients with wild-type RAS metastatic colorectal cancer, the video touts "60 minutes or less of infusion time" and "No premedication," the latter shown beside a crossed-out intravenous bag, the FDA said. The agency said the video "entirely omits risk information" even though Vectibix carries a boxed warning for dermatologic toxicity, the FDA's most serious label warning, along with other serious and potentially fatal risks such as infusion reactions, pulmonary fibrosis and interstitial lung disease.
The FDA also said the video suggests Vectibix is for general treatment of wild-type RAS disease. It does not specify the regimens in which the drug is approved, or its limits of use: it is not indicated for RAS-mutant disease unless combined with sotorasib in KRAS G12C-mutated cases, or where RAS mutation status is unknown.
What Amgen has to do
A warning letter is the FDA's formal notice of violations, not a fine or a ban on sales. The agency told Amgen to take immediate action, including stopping misleading promotion. It said failure to adequately address the violations may bring legal action without further notice, including seizure and injunction.
Amgen must reply in writing within 15 working days of receipt. The response should list other Vectibix promotional communications with similar claims and lay out a plan to discontinue them. The FDA also asked for a plan to send corrective communications to the audiences that received the video, using the same media and, generally, the same duration and frequency. If Amgen believes it is not in violation, it may include its reasoning.
The letter adds that its concerns are not necessarily an exhaustive list of potential violations.
The company and the stock
Amgen discovers, develops, manufactures and delivers medicines for serious diseases. Its marketed products include Repatha, Otezla, ENBREL, Prolia and EVENITY, plus the cancer drugs BLINCYTO, KYPROLIS and Vectibix. Product sales were $35,148 million in 2025, per its annual report.
AMGN traded at $447.29 in Tuesday trading, for a market value of $240.4 billion.
Amgen's reply is due within 15 working days of receipt, and the FDA signed the letter on Aug. 12.
Sources
- Warning letter — Amgen Inc. (MARCS-CMS 739641) — U.S. Food and Drug Administration
- AMGEN APPOINTS DAVID W. GIBBS TO BOARD OF DIRECTORS | Nasdaq — nasdaq.com
- Amgen Stock: A Biotech Bargain Heading Into Q3 Earnings (NASDAQ:AMGN) — seekingalpha.com
- Amgen (AMGN) Reports Next Week: Wall Street Expects Earnings Growth — Yahoo Finance
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- AMGEN APPOINTS DAVID W. GIBBS TO BOARD OF DIRECTORS – Company Announcement - FT.com — Financial Times
