The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration warned Amgen Inc. in warning letter 739641, dated August 12, 2026 and posted on October 27, 2026, that promotional video USA-954-81023 for Vectibix (panitumumab), BLA 125147, is false or misleading and misbrands the drug. Other US sponsors of boxed-warning oncology biologics that submit Form FDA 2253 materials must immediately review those materials for balanced risk presentation and full indication disclosure, including limitations of use, under 21 CFR 202.1(e), or face an FDA warning letter, with potential seizure and injunction for uncorrected violations.
Amgen filed video USA-954-81023 under Form FDA 2253 (MA 1067). The letter says it cites "60 minutes or less of infusion time" and "No premedication", and omits every risk, including the boxed warning for dermatologic toxicity, plus the line-of-therapy limits and the limitations of use.
- Authority : FDA Office of Prescription Drug Promotion (OPDP)
- Entity : Amgen Inc.
- Measure and amount : warning letter, no fine at this stage
- Legal basis : 21 U.S.C. 352(a), (n); 321(n); 331(a); 21 CFR 202.1(e)(3)(ii) and (iii); (e)(5)
- Decision date : August 12, 2026 (posted October 27, 2026)
- Appeal or compliance window : written response within 15 working days of receipt
- Official source : FDA warning letter 739641 to Amgen Inc.
What happened
OPDP told Amgen to cease the misleading communications and to answer within 15 working days of receipt: list other Vectibix pieces with the same claims and each Form FDA 2253 date, plan to stop them or to cease distribution, and send non-promotional corrections to the same audience (eCTD sequence 6591, BLA 125147, heading 1.15.1.6).
The breach
The letter cites 21 U.S.C. 352(a) and (n), 321(n) and 331(a), and 21 CFR 202.1(e)(3)(ii) and (iii) and (e)(5). It states: "The video is misleading because it includes representations about the benefits of Vectibix but fails to communicate any risk information." It also states: "The video is misleading because it fails to provide material information regarding Vectibix's full FDA-approved indication, including important limitations of use."
The letter restates the label: adult wild-type RAS (KRAS and NRAS) metastatic colorectal cancer, first-line with FOLFOX or monotherapy after fluoropyrimidine, oxaliplatin and irinotecan. Not for RAS-mutant mCRC except with sotorasib in KRAS G12C-mutated disease, and not when RAS status is unknown. The video suggests general use and omits those limits.
Who else is in the same regime
Other US sponsors of boxed-warning oncology biologics that submit Form FDA 2253 materials are in the same regime under 21 CFR 202.1(e). The letter names Amgen Inc. only.
What to check now
- Pair each benefit claim in an HCP video with the boxed warning under 21 CFR 202.1(e)(3).
- Match the on-screen indication to line of therapy and the labeled combination.
- State limitations of use, including populations the drug is not indicated for.
- Stop a piece that omits those facts and send a non-promotional correction to the same audience.
Continuous, per-jurisdiction monitoring in Obsidian surfaces an OPDP warning letter of this kind when the FDA posts it.
