FDA continues ad enforcement push with first two untitled letters 2026

The US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued its first two untitled letters of the year to two companies, Altor BioScience and BeOne Medicines alleging that the companies made false or misleading claims on their websites or in TV advertisements. The companies have been given 15 days to respond to the letters.

The issuance of untitled letters follows a surge in FDA enforcement activity concerning prescription drug promotion that kicked off in September 2025, during which the agency sent more than 100 warning and untitled letters to drug manufacturers over promotional claims made about their products. (RELATED: FDA posts more than 100 warning and untitled letters in ad crackdown, Regulatory Focus 16 September 2025; FDA cracks down on drug ads, promises to end adequate provision ‘loophole’, Regulatory Focus 10 September 2025)

Altor BioScience

FDA sent an untitled letter to Summit, NJ-based Altor BioScience on 7 January regarding promotional claims on its webpage for Anktiva (nogapendekin alfa inbakicept-pmln), which is intended to treat bladder cancer.

The letter stated that the company’s website inaccurately represented efficacy claims related to cystectomy avoidance, which involves removing the bladder, and disease-specific survival, which the agency said lacked support from studies.

The website asserted that 84% of patients participating in a study were free from a cystectomy at 36 months, and that 99% experienced disease-specific overall survival during the same time period. The webpage also stated that “84% of patients who responded to ANKTIVA were able to keep their bladders at 36 months and 99% had disease-specific overall survival at 36 months.

FDA states that these claims misrepresent the results of the QUILT-3.032 study on this treatment. The study, said FDA, “was not capable of establishing improvement on these time-to-event efficacy endpoints. Anktiva was approved based on an effect shown on complete response and duration of response in QUILT-3.032, a single-arm study.”

The agency noted that a previous untitled letter was sent to the company in September 2025 related to claims made about Anktiva that “addressed similar claims and representations.” In that correspondence, FDA requested that Altor cease and desist disseminating promotional communications that were misleading.

FDA expressed concern that stated that Altor “appears to be promoting Anktiva using similar claims and representations in a misleading manner.”

BeOne Medicines

The second untitled letter was also issued on 7 January to BeOne Medicines USA in Pennington, NJ, for its claims in TV advertisements regarding Brukinsa (zanubrutinib) capsules and tablets for oral use. These advertisements were also deemed “false or misleading” by FDA.

Brukinsa kinase inhibitor is indicated to treat several types of B-cell cancers in adults such as mantle cell lymphoma, Waldenström macroglobulinemia, and relapsed or refractory marginal zone lymphoma.

FDA said the TV ad featured an older man who looks confused as he is presented with questions about treatment options and possible next steps related to his CLL diagnosis. In the next scene, the man is shown in a serene environment as he travels up a mountain on a gondola. He is seen in the gondola wearing a hopeful grin as benefit claims are presented both audibly and visually. The final scenes of the ad depict the man smiling and overlooking a vast landscape from the mountaintop with his family.

FDA wrote that “the totality of these claims and presentations creates a misleading impression regarding the risk profile of Brukinsa.” The TV ad implies that patients are able to travel long distances once they are on the medicine, yet adverse reactions are most likely to occur when patients start using the drug or when the dosage changes.

FDA further noted that “patients on Brukinsa are required to be seen by their health care provider on a regular basis to assess the drug’s efficacy and potential adverse effects. Therefore, these claims and presentations create a misleading impression that patients on Brukinsa can maintain a normal, active lifestyle, thereby downplaying the serious side effects and monitoring requirements.”

Also, the major statement is presented at the peak of the TV ad where the man reaches the top of the mountain and exits the gondola while holding hands with his wife. He then meets the rest of his family on top of the mountain, where he is seen laughing and hugging them.

FDA stated that “the TV ad is misleading because these compelling and attention-grabbing visuals during the presentation of the major statement interfere with comprehension of the major statement.”

Altor BioScience; BeOne

FDA continues ad enforcement push with first two untitled letters 2026

Related topics

Recommended content

Welcome to the new RAPS Digital Experience