FDA 就 VECTIBIX（panitumumab）宣传视频向 Amgen 发出警告信（BLA 125147）

Product:

Drugs

Recipient:

Recipient Name

Robert Bradway

Recipient Title

Chairman and Chief Executive Officer

Amgen Inc.

1 Amgen Center Dr.
Thousand Oaks, CA 91320
United States

Issuing Office:

Office of Medical Policy

United States

Secondary Issuing Offices

United States

WARNING LETTER

RE: BLA 125147
VECTIBIX® (panitumumab) Injection for intravenous use
MA 1067

Dear Robert Bradway:

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a video (USA-954-81023) (video) for VECTIBIX® (panitumumab) Injection for intravenous use (Vectibix) submitted by Amgen Inc. (Amgen) under cover of Form FDA 2253. FDA has determined that the video is false or misleading. Thus, the video misbrands Vectibix and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1(e)(3)(ii) and (iii); (e)(5). These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety and effectiveness of Vectibix, a treatment for a certain type of colorectal cancer. Colorectal cancer is a significant public health concern as it is the second leading cause of cancer deaths in the United States,¹ and its treatment involves serious and potentially fatal risks. Specifically, Vectibix bears a boxed warning due to the risk of dermatologic toxicity, as well as a number of other serious and potentially fatal risks, such as infusion reactions, pulmonary fibrosis, and interstitial lung disease.

Background

Below are the indication and summary of the most serious and most common risks associated with the use of Vectibix.² According to the INDICATIONS AND USAGE section of the FDA-approved Prescribing Information (PI) (emphasis original, in pertinent part):

Vectibix is indicated for the treatment of adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) metastatic colorectal cancer (mCRC):

• As first-line therapy in combination with FOLFOX.
• As monotherapy following disease progression after prior treatment with
fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy …

Limitations of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown.

The PI for Vectibix includes a boxed warning regarding dermatologic toxicity. The PI for Vectibix includes warnings and precautions regarding dermatologic and soft tissue toxicity, increased tumor progression, increased mortality, or lack of benefit in patients with RAS-mutant mCRC receiving Vectibix monotherapy or in combination with oxaliplatin-based chemotherapy, electrolyte depletion/monitoring, infusion reactions, acute renal failure, pulmonary fibrosis/interstitial lung disease (ILD), photosensitivity, ocular toxicities, increased mortality and toxicity with Vectibix in combination with bevacizumab and chemotherapy, and embryo-fetal toxicity. The most common adverse reactions of Vectibix as monotherapy are skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea. The most common adverse reactions of Vectibix in combination with FOLFOX chemotherapy are diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin.

False or Misleading Risk Presentation

Prescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to risk. The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.

The video is misleading because it includes representations about the benefits of Vectibix but fails to communicate any risk information. For example, the video includes the following under the bolded header “For adult patients with wild-type RAS* mCRC” (emphasis original, footnotes omitted):

• “60 minutes or less of infusion time …”
• “No premedication” in direct conjunction with a visual of an intravenous bag that is
crossed out
• Imagery of a colon

The video, however, entirely omits risk information. By omitting the risks associated with Vectibix, the video fails to provide material information about the consequences that may result from the use of Vectibix and creates a misleading impression about the drug’s safety. This omission is especially problematic from a public health perspective given the serious and potentially fatal risks associated with the drug.

Omission of Material Facts

The video is misleading because it fails to provide material information regarding Vectibix’s full FDA-approved indication, including important limitations of use. Specifically, the INDICATIONS AND USAGE section of the PI states the following (underlined emphasis added, in pertinent part):

Vectibix is indicated for the treatment of adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) metastatic colorectal cancer (mCRC):

• As first-line therapy in combination with FOLFOX.
• As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy …

Limitations of Use: Vectibix is not indicated for the treatment of patients with RAS-mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown.

The video suggests the use of Vectibix for the general treatment of wild-type RAS mCRC, but does not specify that Vectibix is indicated in specific regimens based on its line in therapy, as noted above. In addition, the video fails to disclose Vectibix’s limitations of use, including that it is not indicated in KRAS G12C-mutated mCRC unless used in combination with sotorasib, and that it is not indicated if the RAS mutation status is unknown. By failing to adequately communicate the full indication for Vectibix and limitations of use associated with Vectibix, the video creates a misleading impression about the drug’s FDA-approved indication and use.

Conclusion and Requested Action

For the reasons described above, the video misbrands Vectibix and makes the distribution of the drug in violation of the FD&C Act. 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1(e)(3)(ii) and (iii); (e)(5).

This letter notifies you of our concerns and provides you with an opportunity to address them. You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all other promotional communications (with the 2253 submission date) for Vectibix that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Vectibix.

If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter.

Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter. We recommend that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand Vectibix; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). Corrective communication(s) should be free of promotional claims and presentations. To the extent possible, corrective communication(s) should be distributed using the same media, and generally for the same duration of time and with the same frequency as the promotional communication(s) identified in the opening paragraph of this letter.

The concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations. It is your responsibility to ensure compliance with each applicable requirement of the FD&C Act and FDA implementing regulations.

Please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901- B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 1067 in addition to the BLA number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Additionally, the response submission should be coded as an Amendment to eCTD Sequence 6591 under BLA 125147. Questions related to the submission of your response letter should be emailed to [email protected]

Sincerely,
{See appended electronic signature page}
Kathleen Klemm, PharmD, MS, RAC
Director
Division of Advertising & Promotion Review 1
Office of Prescription Drug Promotion

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This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
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/s/
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KATHLEEN KLEMM
08/12/2026 11:02:07 AM

1. 1SEER Cancer Stat Facts: Colorectal Cancer. National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/statfacts/html/colorect.html (accessed August 12, 2026).
2. 2This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional communication(s) cited in this letter.