The warning letter is directed at promotional claims about Anktiva’s efficacy and use.
FDA issued a warning letter citing misleading promotional materials related to ImmunityBio cancer therapy Anktiva.
Emerging Pharma Leaders nominations are now open!
Do you know someone who can make tough decisions that continue to face manufacturers? Are they destined to change the future of pharma?
Nominate a colleague with impressive leadership and career intentions – even yourself! – for the Pharmaceutical Executive 2026 Emerging Pharma Leaders Awards.
The warning letter raises both regulatory and commercial questions even as analysts maintain sales outlook for the product.
Following the agency’s letter, shares of ImmunityBio fell 26%.1
According to FDA, the agency’s Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer television advertisement and a podcast featuring company leadership made false or misleading claims about the drug’s efficacy and approved use.2
The advertisements, which include appearances by CEO Richard Adcock and executive chairman Patrick Soon-Shiong, suggest that Anktiva could cure cancer, prevent recurrence, and act broadly across multiple tumor types, claims the FDA said are not supported by available evidence or the product’s labeling.2
Anktiva was approved back in April 2024 for a specific form of bladder cancer: Bacillus Calmette-Guérin-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ, when used in combination with BCG.1
The FDA emphasizes that the promotional content failed to clearly communicate the limited indication and instead implied broader applicability, including treatment of “all cancers” and potential use as a cancer-preventive therapy.2
The warning letter also raised concerns about representations of how the drug is administered. While Anktiva is approved for intravesical use only, the promotional materials included descriptions and imagery suggesting it could be given as an injection, including subcutaneously.2
The FDA notes that such claims could mislead patients about safe and appropriate use, particularly given the lack of evidence supporting alternative routes of administration.
Beyond efficacy claims, regulators point to the omission and minimization of risk information. The television ad presents benefit claims prominently, with risk disclosures appearing only at the end, after visual cues suggesting the ad had concluded.
The podcast, meanwhile, included no discussion of safety risks. According to the FDA, this imbalance created a misleading impression of the therapy’s safety profile.
The agency also highlighted that the podcast was not submitted at the time of dissemination as required under federal regulations, and noted that prior communications in 2025 and early 2026 had already raised similar concerns about the company’s promotion of Anktiva.2
The regulatory action comes as ImmunityBio continues to commercialize the therapy. The company reported global Anktiva sales of $113 million in 2025, with analysts projecting growth to approximately $217.6 million this year, according to LSEG data.1
ImmunityBio said it is reviewing the letter and plans to respond within the agency’s required 15 working days.1
At the core of the FDA’s concerns is the disconnect between the clinical evidence supporting Anktiva and the broader claims made in promotional materials. The drug’s approval was based on results from a single-arm study evaluating complete response and duration of response, without a comparator arm capable of establishing outcomes such as disease-free survival. As a result, the FDA stated it is not aware of data supporting claims that the therapy can cure cancer or prevent recurrence.1
The agency directed ImmunityBio to cease the violative promotional materials and to develop corrective communications to address the misleading impressions conveyed to patients and providers.2
Failure to adequately resolve the issues could result in further enforcement actions, including seizure or injunction.
