Amgen Vectibix FDA warning letter flags missing risk information

The Amgen Vectibix FDA warning letter alleges that a promotional video omitted all risk information and material limits on the approved indication. Kathleen Klemm electronically signed it on August 12, 2026. FDA posted the letter on October 27. The letter asks for immediate corrective action and a written response within 15 working days of receipt.

The letter applies existing promotional requirements. It doesn't announce a new regulation, recall or withdrawal of Vectibix's approval.

What FDA found in the Vectibix promotional video

FDA's Office of Prescription Drug Promotion reviewed video USA-954-81023 for Vectibix (panitumumab). Amgen had submitted it under cover of Form FDA 2253. FDA did not allege a missed submission. The letter says the video is false or misleading and misbrands Vectibix. Its headings are "False or Misleading Risk Presentation" and "Omission of Material Facts."

According to FDA, the video stated "60 minutes or less of infusion time ..." and "No premedication." The second claim sat beside a crossed-out intravenous-bag image. The objection was that the video "entirely omits risk information," not a separate finding that those convenience claims were inherently false. Those details are FDA's account of the video.

The letter's risk background names a boxed warning for dermatologic toxicity and other risks, including potentially serious infusion reactions. But FDA says that background does not necessarily represent the risk information this communication should have included. Don't treat the background list as a required script for the video.

Why the indication wording was incomplete

FDA also quotes the header "For adult patients with wild-type RAS* mCRC." The agency says the video suggested general treatment of wild-type RAS metastatic colorectal cancer without the treatment line and the regimen. The letter sets out those missing qualifications.

Both KRAS and NRAS must be wild-type, determined by an FDA-approved test. The Vectibix label then specifies:

• First-line treatment with FOLFOX.
• Monotherapy after disease progression following prior fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.

A separate indication covers Vectibix with sotorasib for adults with KRAS G12C-mutated mCRC, confirmed by an FDA-approved test, after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. FDA approved that combination on January 16, 2025. Unknown RAS status is not indicated.

What FDA requested from Amgen

The 15 working days run from receipt. October 27 does not start a new clock.

The letter does not state Amgen's receipt date.

FDA asked Amgen to stop misleading communications immediately. It also asked for other Vectibix materials with similar representations, their Form 2253 submission dates, and a plan to discontinue those similar materials or to cease distribution of Vectibix. That distribution wording is a request, not evidence that distribution stopped. If Amgen disputes the violations, the response has to include the reasoning. The August 12 letter also warns of possible further legal action without further notice, including seizure and injunction.

FDA also asked for corrective communications to the audiences that received the original promotion. Recommended corrections identify the original material, correct each concern and contain no promotional claims. Where possible, they use the same media, duration and frequency. These remain requests and recommendations, not a report that a correction has already gone out.

What promotion teams should review

Check benefit claims against the risks and indication limits in the same material, then do that for similar Vectibix pieces and keep the 2253 dates. Plan any correction so it reaches the original audience. Those checks follow FDA's requests in this letter.

You can also try RegAffairs AI's drug-promotion compliance Q&A. For the case findings and requested response, use the Amgen warning letter itself.