ImmunityBio Warning Letter Over Misleading Promotion of Anktiva

FDA has issued a Warning Letter to ImmunityBio, citing misleading promotional claims about its cancer therapy Anktiva (nogapendekin alfa inbakicept-pmln) in both a television advertisement and a podcast appearance by company leadership. In the just-posted 3/13 letter, CDER Office of Prescription Drug Promotion (OPDP) says the company’s marketing materials “misbrand” the drug by overstating its effectiveness, omitting critical safety information, and promoting uses not approved by regulators.

The letter is the latest from the agency as part of its ongoing crackdown on direct-to-consumer and other promotional prescription drug activities. Legal observers have recently raised concerns with FDA’s increased enforcement activity. A legal update from lawyers at Sidley says the agency letters often articulate positions that “raise significant constitutional, legal, and regulatory concerns.” Their legal update notes that a recent Untitled Letter directly conflicts with a position the agency stated in a Warning Letter issued more than 20 years ago, which recognized that factual statements about a medical product’s approved indications are truthful, non-misleading, and not objectionable.

Regarding Anktiva, the center of the agency’s concerns is statements made in a TV ad and a January 2026 podcast episode featuring Patrick Soon-Shiong, ImmunityBio’s executive chairman and chief scientific officer. In those appearances, the company suggested that Anktiva could potentially “cure cancer,” treat multiple cancer types, and even prevent cancer following radiation exposure.

The FDA said such claims are not supported by clinical evidence and significantly overstate the drug’s demonstrated benefits. Anktiva is currently approved only for a narrow indication: use in combination with Bacillus Calmette-Guérin (BCG) for certain adults with BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ.

Regulators emphasize that clinical data for the therapy — based on a small, single-arm study — do not establish that the drug can prevent recurrence in all patients, improve long-term survival outcomes, or act as a standalone treatment.

The Warning Letter also highlights statements promoting Anktiva for unapproved uses, including treatment of “all cancers,” lung cancer after failure of other therapies, and cancer prevention. FDA says these claims indicate the drug is being marketed beyond its approved label, without adequate directions for such uses.

Additionally, the agency says misleading depictions of how the drug is administered are bothersome. Promotional materials suggested it could be given as an injection, while the approved labeling specifies it is for intravesical (bladder) use only.

Another major issue cited by regulators is the lack of balanced risk information. While the TV ad emphasized potential benefits, safety details were relegated to the end of the advertisement after a visual fade-out, reducing their visibility. The podcast, meanwhile, included no discussion of risks at all.

FDA says this imbalance could leave patients with a dangerously incomplete understanding of the therapy, particularly given the serious risks associated with delayed surgical treatment in bladder cancer.

The agency notes that this is not the first time ImmunityBio has been flagged for similar concerns. Previous “untitled letters” sent in 2025 and early 2026 raised issues about misleading presentations of clinical data tied to the same drug.

In addition, FDA says the company failed to properly submit the podcast as promotional material at the time of its initial dissemination, as required by federal regulations.

FDA has directed ImmunityBio to immediately cease dissemination of the misleading materials and to respond within 15 working days with a plan to address the violations. The agency also calls for corrective communications to be issued to audiences who were exposed to the promotional claims.