The U.S. Food and Drug Administration issued a warning letter to ImmunityBio on March 13, 2026, saying the company spread misleading claims about its cancer drug Anktiva through a broadcast television ad and a podcast featuring Executive Chairman Patrick Soon-Shiong. The letter follows two earlier OPDP untitled letters since September 2025 that raised similar concerns about promotional materials, underscoring how executive-led media appearances can be treated as regulated drug promotion when they discuss a product beyond its approved use.
What the FDA Found in the Promotions
The FDA’s Office of Prescription Drug Promotion reviewed two pieces of direct-to-consumer content: a broadcast TV ad cataloged as US-ANK-250065-v1 and a podcast titled “Is the FDA BLOCKING Life Saving Cancer Treatments?” The podcast featured Soon-Shiong, who is identified in the OPDP letter as ImmunityBio’s Executive Chairman and Global Chief Scientific Officer. Both pieces of content were submitted to the agency under Form FDA 2253, the standard mechanism for reporting promotional materials.
According to the agency, the materials presented efficacy claims that went well beyond the drug’s narrow approval. The FDA described the promotional strategy as featuring “consistent and pervasive” messaging that overstated benefits and suggested broad cancer-fighting powers. That language signals the FDA views this not as a one-off error but as a pattern of overstating what Anktiva can deliver to patients and physicians.
In particular, the agency said the TV ad and podcast implied that Anktiva could help patients avoid chemotherapy, prevent cancer from spreading, and serve as a generalized “immunotherapy” solution, without making clear that its approval is limited to a specific form of bladder cancer. The FDA also faulted the materials for minimizing risks by failing to present safety information with comparable prominence to the touted benefits. When consumers hear sweeping claims about life-saving potential in a broadcast or podcast, the omission of context about who the drug is actually for can leave them with an inflated impression of what it can do.
A Narrow Approval for a Specific Cancer
The gap between what ImmunityBio promoted and what the FDA actually approved is the core tension in this case. The agency approved nogapendekin alfa inbakicept-pmln, branded as Anktiva, on April 22, 2024, for use with BCG in treating BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. The indication, described in the FDA’s approval notice, is highly specific: a particular subtype of bladder cancer in patients who have already failed a standard treatment.
The approval rested on the QUILT-3.032 trial, which was open-label, single-arm, and multicenter, with a safety population of 88 patients and an efficacy-evaluable subset of 77 patients, according to the FDA’s trial snapshot. The drug is administered by intravesical catheter instillation into the bladder, mixed with BCG. Single-arm trials lack a control group, which means they can show whether patients respond to treatment but cannot prove the drug performs better than alternatives. That design limitation becomes critical when promotional materials imply superiority over chemotherapy, suggest the drug can prevent cancer broadly, or hint at benefits in tumor types never studied in the pivotal trial.
Three FDA Letters in About Six Months
The March 2026 warning letter did not arrive in isolation. The OPDP had already flagged ImmunityBio twice before for similar conduct. Per the untitled letter from September 2025, regulators objected to representations claiming “84% cystectomy free at 36 months” and “99% DSS at 36 months,” finding these statistics misleading given the QUILT-3.032 trial’s single-arm design and the inability to interpret time-to-event outcomes without a comparator group.
A second untitled letter, described in an OPDP notice in January 2026, was directed at Altor BioScience, an ImmunityBio subsidiary. That letter found healthcare-professional and consumer webpages false or misleading for presenting the same cystectomy avoidance and disease-specific survival statistics. The repeated use of identical claims across different channels and corporate entities, even after regulatory warnings, suggests the company continued to deploy these figures as marketing tools despite being told they were misleading.
This escalation from untitled letters to a formal warning letter carries real regulatory weight. Untitled letters typically request voluntary corrections and serve as an early signal that the agency sees problems. Warning letters, by contrast, are a more serious step in FDA’s compliance process and can precede additional enforcement if violations are not corrected. They also become public, sending a message to the broader industry about where regulators are drawing the line on promotional speech.
Why the Claims Mislead Patients
For patients facing a bladder cancer diagnosis, the distinction between what Anktiva was proven to do and what ImmunityBio’s promotions implied matters enormously. Telling a patient that 84% of people avoided cystectomy, the surgical removal of the bladder, at 36 months sounds like strong evidence. But when that number comes from a single-arm trial of 77 evaluable patients with no comparison group, the statistic cannot tell patients whether Anktiva performed better than any other option. It only tells them what happened to a small group of people who received the drug.
The same problem applies to the 99% disease-specific survival claim. Without a control arm, there is no way to attribute that survival rate to the drug rather than to patient selection, the natural course of the disease in that subgroup, or other factors. Presenting these numbers in direct-to-consumer ads and on patient-facing websites without adequate context risks giving patients inflated expectations about what the drug can do. The FDA’s concern, stated in the warning letter, is that such claims could lead to “inappropriate use” by suggesting that patients can safely forgo more established therapies.
Misleading promotions also complicate conversations between oncologists and their patients. When someone arrives at an appointment having heard that a drug can “save your bladder” or “stop cancer from coming back,” it can be difficult to explain the nuances of trial design, eligibility criteria, and real-world uncertainty. The emotional stakes are high, and exaggerated marketing can crowd out more balanced, evidence-based discussions about risks, benefits, and alternatives.
Soon-Shiong’s Dual Role Amplifies the Risk
Patrick Soon-Shiong is not a typical pharmaceutical executive. He is a billionaire physician-entrepreneur whose profile in national reporting highlights his ownership of media outlets and his history of promoting ambitious cancer projects. In the podcast cited by the FDA, he appears not only as a company leader but as a medical authority and public figure, speaking directly to patients and caregivers about Anktiva’s potential.
That dual role amplifies the impact of any misleading statements. When a CEO frames regulatory scrutiny as bureaucratic obstruction or hints that a drug is being unfairly “blocked,” listeners may interpret scientific disagreements as political or personal conflicts. The FDA’s letter underscores that even when executives speak on seemingly editorial platforms like podcasts, their comments about approved products can still count as promotional labeling or advertising subject to regulation.
The case also illustrates how personal media brands can blur the line between journalism, advocacy, and marketing. A podcast episode that poses a provocative question about whether regulators are standing in the way of “life saving” treatments may attract attention and sympathy, but if it also includes unbalanced claims about a specific drug’s benefits, it can undermine the guardrails that exist to protect patients from hype.
What Comes Next for Patients and Regulators
The warning letter calls for ImmunityBio to respond in writing, detailing how it will correct the violations and prevent recurrences. The FDA can follow up with inspections, additional correspondence, or, in more severe cases, enforcement actions that affect the company’s ability to market its products. For now, the agency is using the warning letter to demand that the company cease the problematic promotions and disseminate accurate information about Anktiva’s approved use and limitations.
Patients and clinicians who encounter questionable claims about Anktiva or other drugs can report concerns through the FDA’s MedWatch portal, which collects safety and quality complaints as well as issues related to product use. Those reports, combined with the agency’s own monitoring of advertisements and online content, help regulators identify patterns of misleading promotion earlier.
More broadly, the ImmunityBio case may serve as a test of how aggressively the FDA will police drug promotion in an era where executives can reach millions through podcasts, social media, and streaming video. As the agency’s language about “consistent and pervasive” misstatements suggests, regulators are watching not only what appears on traditional ads but also how companies and their leaders talk about medicines across the full spectrum of media. For patients navigating complex treatment choices, the outcome will shape how much they can trust that what they hear about a cancer drug reflects the evidence, not just the enthusiasm of those selling it.
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*This article was researched with the help of AI, with human editors creating the final content.
