The FDA has issued an untitled letter to BeOne Medicines’ U.S. subsidiary over a TV commercial promoting its BTK blood cancer drug Brukinsa, saying the ad used “compelling and attention-grabbing visuals” that did not hold up to scrutiny.
The Office of Prescription Drug Promotion (OPDP) took issue with a new ad, first aired in February, called “Clarity.” In the commercial, a middle-aged woman is seen looking to cross a bridge in the mountains but appearing unsure.
The narrator then says, “Brukinsa brings clarity to your path ahead,” prompting the woman to walk across the bridge. In the final scenes, the woman smiles while overlooking a vast mountain landscape with a friend as the voiceover says, “See your future clearly again … Clearly Brukinsa.”
The FDA said the ad “misleadingly suggests that Brukinsa will allow patients to ‘see their futures clearly’ by leaving treatment considerations or concerns aside.”
The regulator explained that patient reported outcomes from BeOne’s pivotal trials for the drug “do not support the suggestion that patients on Brukinsa will ‘see their futures clearly’ by improving their quality of life.”
“Specifically, these data are subject to bias given the open-label trial design, were not analyzed based on a prespecified hypothesis, were not controlled for multiplicity and thus are considered descriptive in nature,” the agency said.
The FDA added that the overall effect of the ad and its “emotional arc” is “misleading because these compelling and attention-grabbing visuals during the presentation of the major statement [bringing clarity] interfere with comprehension of the major statement.”
The OPDP also said the ad’s safety claim that “Brukinsa had low rates of cardiovascular events including afib [atrial fibrillation]” was misleading because a “superior safety profile—particularly, a lower risk of cardiovascular events, including afib … was not demonstrated.”
The agency specifically cited comparisons to rival BTK inhibitor Imbruvica from Johnson & Johnson, saying the ad suggested Brukinsa may be the “best” chronic lymphocytic leukemia treatment.
As is standard, the FDA gave the company 15 days from receipt of the letter, which was posted on the agency’s website May 13, to respond and revise the ad.
Brukinsa has FDA approvals in mantle cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma and follicular lymphoma.
The drug generated $3.9 billion in sales in 2025, up 49% year over year.
BeOne told Fierce Pharma Marketing in a statement: "BeOne is committed to maintaining the highest standards in product communications for healthcare professionals and patients, ensuring accuracy, balanced presentation of efficacy and safety, and appropriate contextual information. We are reviewing the letter and will respond directly to the FDA within the requested timeframe."
The drugmaker has now earned the ire of the OPDP again—at the start of the year it was hit with an untitled letter for another very similar ad.