The steady stream of FDA untitled letters that began in September is showing no signs of letting up in the new year.
The regulator’s Office of Prescription Drug Promotion (OPDP) has already sent out two letters alleging “false or misleading” promotional materials in 2026, both dated Jan. 7 and sent to ImmunityBio and BeOne Medicines. BeOne is also the subject of another letter from December that was belatedly uploaded to the FDA website this month.
The untitled letter (PDF) to ImmunityBio concerns a pair of pages on the healthcare professional- and consumer-facing websites for bladder cancer drug Anktiva. Both pages include statistics claiming that 84% of Anktiva responders were able to avoid cystectomy—meaning they were able to keep their bladders—at 36 months and that disease-specific overall survival at 36 months came in at 99%.
According to the FDA, however, the trial referenced by the data points “was not capable of establishing improvement on these time-to-event efficacy endpoints” because it was a single-arm study.
“Absent an appropriate comparator, it is not possible to determine if the observed effect is attributable to Anktiva or to other factor(s), such as the natural history of the disease,” the regulator wrote.
The letter acknowledged that footnotes attached to the statistics advise readers to interpret them “with caution and in the context of the study’s limitations of a single-arm study,” while maintaining that the warning “does not render the promotional communication nonmisleading.”
The FDA also noted that its concerns are similar to those outlined in another untitled letter it sent to ImmunityBio in September, writing, the “OPDP is concerned that Altor appears to be promoting Anktiva using similar claims and representations in a misleading manner." Altor is the ImmunityBio subsidiary addressed directly in the FDA's letter.
“Like many other companies, we recently received feedback from the FDA related to specific content on our website," ImmunityBio said in a statement sent to Fierce Pharma Marketing. "We are working with the Agency to address their concerns. We remain committed to accurate, compliant communication and do not expect any impact on our products or clinical programs.”
The Jan. 7 letter (PDF) to BeOne, meanwhile, homes in on a TV ad for blood cancer drug Brukinsa.
The minute-long commercial starts with its subject, a chronic lymphocytic leukemia (CLL) patient, lacking clarity about his treatment path. Brukinsa offers that clarity, according to the ad, which goes on to share information about the med’s uses, risks and side effects in a voiceover as the man, now hopeful, is shown going on a gondola ride up the side of a mountain with his wife to meet more loved ones. The ad ends with the tagline, “See your future clearly again with Brukinsa.”
According to the FDA, the ad’s imagery suggests that “when it’s time for treatment with Brukinsa, patients are able to travel long distances or for prolonged periods since they are ‘in control’ of their CLL treatment”—though that’s not explicitly stated in the clip—which would be misleading since “adverse reactions are most likely to happen when patients start using the drug or when the dosage changes.”
The regulator also took issue with moments throughout the commercial in which safety information in the major statement is either given only via voiceover or in on-screen text, rather than in the required “dual modality.”
Finally, the FDA suggested that the major statements being presented at the peak of the ad’s “emotional story arc” may distract viewers from the drug’s safety information.
Meanwhile, the belatedly posted Dec. 17 untitled letter (PDF) to BeOne takes issue with a pair of Microsoft Teams meeting backgrounds promoting Tevimbra. Because the images each make claims about the drug—that it’s “bringing more to the table” and is “approved," respectively, in some upper GI cancers—they must also include information about its full indication and risks, none of which has been provided in the Teams backgrounds, per the FDA.
In both cases, the agency gave BeOne 15 working days to respond to its concerns about the materials. The company did not respond to Fierce’s request for comment.