Pfizer: ADCETRIS (brentuximab vedotin)
FDA untitled letter, 8 April 2026. A set of Facebook video ads for Adcetris suggested it was for T-cell lymphoma generally without naming the approved subtypes. FDA also said the ads left out the bleomycin contraindication and fatal outcomes from serious infections, skin reactions and hyperglycemia.
The letter
- Date
- 8 April 2026
- Type
- Untitled letter (OPDP)
- Product
- ADCETRIS® (brentuximab vedotin) for injection, for intravenous use (BLA 125388)
- FDA matter number
- MA 919
- Promoted piece
- ADCETRIS PTCL Facebook Ads Set video ads
- Aimed at
- Consumers (DTC)
- Format
- Social media post, Online video
- Came in under Form FDA 2253
- Yes, the letter says it was submitted on Form FDA 2253
- Close-out
- FDA closed the matter out on 29 April 2026, 21 days after the letter.
Read the letter on FDA.gov · Promoted material (PDF) · Close-out letter
What FDA cited
The categories below are this tool's labels, read from the letter. Each quote is FDA's own wording, copied from the letter.
- Omits or minimizes risk
“By omitting this material risk information, the Facebook ads minimize Adcetris’s risks and create a misleading impression of the drug’s safety.”
- Broader use than approved
“These claims suggest the use of Adcetris for the general treatment of T-cell lymphoma or “certain” previously untreated CD30-expressing peripheral T-cell, but they do not specify the subtypes noted above.”
Check your claims before FDA does
Arca reads a promotional piece against the approved labeling and the references it cites, and flags each claim the label does not support. See how Arca supports MLR review. Back to the OPDP letter search.