Federal health regulators have formally warned ImmunityBio Inc. for making misleading promotional claims about Anktiva, the company’s bladder cancer drug. Dr. Patrick Soon-Shiong, the company’s executive chairman, made these claims during a public podcast appearance in January 2026. The FDA determined that the statements were false, misleading, and in clear violation of federal drug marketing law. The warning letter was sent to ImmunityBio CEO Richard Adcock, giving the company 15 working days to respond with a compliance plan.
What Anktiva Is and What It Is Approved For
The FDA approved Anktiva specifically to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in the original location. It works alongside Bacillus Calmette-Guérin, a vaccine commonly used to treat tuberculosis. In a clinical trial involving 77 evaluable patients, the drug achieved a complete response rate of 62%. Before the FDA approved Anktiva, it granted the drug Breakthrough Therapy designation based on these findings. This designation applies to drugs that significantly outperform existing treatments for serious conditions.
How the Drug Works
Anktiva is a new type of immunotherapy that works by upregulating IL-15. It causes the body’s natural killer cells and CD8+ killer T-cells to collaborate to combat tumor cells and establish long-term immune memory. The drug’s mechanism targets a type of bladder cancer that does not respond to BCG vaccine therapy and has not spread to the bladder’s muscle wall. According to ImmunityBio, 75%–85% of all bladder cancer cases are non-muscle invasive. The therapy was created to help patients avoid a radical cystectomy, which is a highly invasive surgical procedure that completely removes the bladder.
Known Side Effects
Anktiva’s documented side effect profile requires drug companies to disclose it in all promotional materials, as mandated by federal regulations. Patients frequently experience elevated creatinine levels, pain or burning during urination, blood in the urine, frequent urination, urinary tract infections, musculoskeletal pain, chills, and fever. Less than 3% of patients suffer severe Grade 3 or 4 adverse reactions due to urinary tract infections, musculoskeletal pain, or high potassium levels. Adverse reactions lead 7% of clinical trial patients to discontinue treatment permanently. During his appearance on “The Sean Spicer Show” podcast, Dr. Patrick Soon-Shiong made several controversial assertions regarding the efficacy of the drug but omitted any mention of its potential adverse side effects.
Expansion Efforts and Prior Regulatory Friction
ImmunityBio actively seeks to expand Anktiva’s approved use beyond bladder cancer. The company pursues approval for various types of lung and pancreatic cancer, among other indications. The FDA denied ImmunityBio’s additional application in 2025 to allow the drug to be used for BCG-unresponsive papillary NMIBC, citing insufficient clinical data. The agency had previously sent untitled letters to Altor BioScience, an ImmunityBio subsidiary, regarding similarly misleading promotional claims for Anktiva. Regulators noted that the company had already received the earlier letters before the March 2026 warning. The history of prior notices plays a critical role in the FDA’s current enforcement posture.
The Statements That Caused the FDA to Issue a Warning
In January 2026, Dr. Patrick Soon-Shiong, ImmunityBio’s executive chairman and chief medical officer, made a series of bold claims regarding Anktiva during his appearance on “The Sean Spicer Show” podcast, titled “Is the FDA blocking life-saving cancer treatments?” During his appearance on “The Sean Spicer Show” podcast, Dr. Patrick Soon-Shiong described the drug as “the most important molecule that could cure cancer.” He claimed moments later, “It actually can treat all cancers.” He also asserted, “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.” However, none of these claims align with the drug’s FDA-approved indication for bladder cancer.
The Television Advertisement
The FDA examined a direct-to-consumer television commercial for Anktiva featuring Soon-Shiong and CEO Richard Adcock, which implied that the medication could prevent recurrence or act as a cancer vaccine. Though Anktiva is only authorized for intravenous (via a catheter) delivery into the bladder, the advertisement featured images that gave the impression that the medication was being administered subcutaneously, which regulators disputed. The FDA stated that this created a misleading impression and could pose dangers. Additionally, the advertisement suggested that Anktiva could serve as a stand-alone treatment, exceeding its approved use.
Labelling the Drug a Cancer Vaccine
The podcast and television advertisements referred to Anktiva as a “cancer vaccine,” but the FDA stated that this description is incorrect. Anktiva functions as an immunotherapy drug approved for a specific cancer type in a narrow patient population. It has not demonstrated the preventive mechanisms that characterize a vaccine. The agency’s warning letter indicated that the drug lacks approval for any cancer prevention use and that its labeling does not provide adequate directions for such applications. The FDA asserted that using the term “vaccine” in this context constitutes misbranding under the Federal Food, Drug, and Cosmetic Act.
Missing Risk Information
Drug promotions must present a balanced view of risks and benefits, as federal law requires. The podcast episode did not discuss the side effects and safety profile of Anktiva. Although the television advertisement included a risk disclosure, regulators observed that it appeared only after visual cues indicated the advertisement had ended. The FDA found that this placement diminished the significance of known adverse reactions and distorted viewers’ perceptions of the benefit-risk balance. The lack of disclosures in the advertisement and the podcast draws attention to a systematic failure to satisfy FDA promotional criteria, instead of only oversight.
The Clinical Pipeline Behind the Controversy
While ImmunityBio’s assertions remain contentious, they exist alongside promising clinical evidence. In January 2026, the company announced findings from 151 patients with non-small cell lung cancer (NSCLC) who participated in the QUILT-2.023 and QUILT-3.055 trials. Those patients who received Anktiva and achieved high immune competence showed a median overall survival of 21.1 months, significantly surpassing the 7 to 9 months typically linked to second-line docetaxel chemotherapy. Following these results, ImmunityBio launched ResQ201A, a confirmatory Phase 3 trial to assess Anktiva alongside a checkpoint inhibitor compared to docetaxel in the same patient group.
Pancreatic Cancer Data and RMAT Designation
In February 2025, the FDA granted ImmunityBio a Regenerative Medicine Advanced Therapy (RMAT) designation, showing that the agency recognized the importance of the company’s clinical data. This RMAT status specifically pertains to Anktiva used with CAR-NK therapy to treat patients with multiple relapses of metastatic pancreatic cancer and to reverse lymphopenia in individuals undergoing radiotherapy or chemotherapy.
This classification aims to accelerate the drug development process and promote more frequent communication between the FDA and manufacturers. After ImmunityBio presented its findings at the 2025 ASCO Annual Meeting, the company celebrated this regulatory achievement. The data demonstrated that the combination of Anktiva and CAR-NK cell therapy significantly improved overall survival for patients with metastatic pancreatic cancer who were on their third to sixth lines of treatment.
Why the Claims Still Violate the Rules
Promising trial data does not release a company from FDA promotional rules. Two separate legal categories are approved indications and findings of clinical trials. No matter how convincing initial data may seem, a drug cannot be promoted for uses it is not yet approved for. The FDA’s worries are not about fake science. Its concern is that Soon-Shiong bypassed the peer review and regulatory evaluation process by directly informing the public of speculative and unapproved uses straight through broadcast media.
Regulatory Consequences and the Broader Enforcement Context
The FDA directed the warning letter to ImmunityBio CEO Richard Adcock. The letter requires the company to respond in writing within 15 working days with a plan to correct the infractions and cease distributing all misleading promotional tools. By the afternoon of March 24, 2026, ImmunityBio’s website had removed a link to the podcast. Correspondent Sarah Singleton of ImmunityBio confirmed via email that the business takes FDA warnings “very seriously” and plans to “work cooperatively with the agency to address the matters raised in the letter.” Non-compliance with a warning letter can lead to product seizure, injunctions, or a referral for criminal prosecution by the Department of Justice.
Market Reaction
On the day the warning letter became public, ImmunityBio’s share price dropped more than 21%. Investors saw shares close at $7.42 on March 24, 2026, a sharp decline from the previous session. The announcement triggered a surge in trading volume, exceeding 86 million shares, while the typical daily average in the weeks before hovered around 17 to 28 million shares. This market reaction revealed investor worries about the company’s regulatory status and the credibility of its broader Anktiva expansion pipeline. A single-day drop of 21% indicates a significant loss of market confidence, especially for a company that heavily relies on that one drug in its pipeline.
Off-Label Enforcement Has Precedent and Weight
The legal foundation supporting the FDA’s decision has significant implications. The Federal Food, Drug, and Cosmetic Act classifies off-label promotion as misbranding, and violations incur strict liability. In 2004, Warner-Lambert settled civil and criminal liability for marketing the epilepsy medication for unapproved uses, paying $430 million and establishing an early benchmark. The Department of Justice has pursued most off-label promotion cases through the civil False Claims Act, which allows penalties of up to three times the actual damages plus $11,000 for each false claim. In 2020, Indivior faced a civil liability settlement of $300 million. While ImmunityBio has not yet faced similar consequences, the warning letter clearly indicates that this enforcement path is a possibility.
The Trump Administration’s Enforcement Push
The ImmunityBio warning does not exist in isolation. In September 2025, President Trump signed a presidential memorandum directing the FDA to crack down on misleading direct-to-consumer pharmaceutical advertising. The administration noted that the FDA had issued only one warning letter to a pharmaceutical company in 2023 and none in 2024. Under the memo, the FDA announced plans to issue thousands of enforcement letters and around 100 cease-and-desist letters to companies with violative advertising. FDA Commissioner Marty Makary stated publicly, “We’re going to be strict on this.” That enforcement posture directly set the stage for the action against ImmunityBio in March 2026.
A Pattern the FDA Cannot Ignore
The FDA’s warning letter explicitly noted prior untitled letters sent to ImmunityBio’s subsidiary Altor BioScience over similar Anktiva claims. The agency stated it was “concerned that, despite receiving these previous Untitled Letters, ImmunityBio continues to promote Anktiva in a similarly misleading manner.” That language is significant. It frames the March 2026 warning not as a first offense but as an escalation in a pattern of non-compliance. The FDA also noted that the podcast was not submitted to the agency at the time of dissemination, as required by federal regulation. Together, those factors suggest the agency views this case as a willful disregard for rules the company already knew applied to them.
Who Is Patrick Soon-Shiong
Patrick Soon-Shiong, a physician, transplant surgeon, and business magnate who was born in South Africa, is a billionaire entrepreneur. He was born on July 29, 1952, in Port Elizabeth, to parents who had immigrated from China and were living in South Africa during the apartheid era. After completing his medical degree at the University of the Witwatersrand in Johannesburg, he left the country and eventually settled in Los Angeles, where he established one of the most peculiar careers in contemporary medicine. Over five hundred patents have been issued to him all over the world, and he has published more than one hundred scientific papers. With a net worth of approximately $16.6 billion as of the year 2026, he is considered one of the wealthiest physicians in the entire world.
The Surgeon Who Rewrote Cancer Treatment
Before Anktiva, Soon-Shiong established his scientific reputation by inventing Abraxane, a protein nanoparticle chemotherapy drug, in the 1990s. He developed a straightforward yet technically challenging concept: encase the chemotherapy compound paclitaxel in albumin protein to enable it to target tumor cells more accurately and reduce side effects. The FDA approved Abraxane in 2005 for metastatic breast cancer and later broadened its approval to include lung and pancreatic cancer. The drug’s annual sales eventually surpassed $1 billion. In 2010, he sold Abraxis BioScience to Celgene for about $3.8 billion. The Smithsonian National Museum of American History included Abraxane in its medical history collections.
NantWorks and the Vision of a Cancer-Free World
Soon-Shiong founded NantWorks in 2011 as an ecosystem of interconnected companies spanning healthcare, artificial intelligence, semiconductors, and data infrastructure. The organization operates what he describes as a private-sector equivalent of Bell Labs, pursuing cancer and infectious disease research outside the constraints of academic institutions and government agencies. Under the NantWorks umbrella sit NantHealth, NantOmics, NantBioscience, and ImmunityBio, among others. He also launched the National Immunotherapy Coalition in 2016, convening rival pharmaceutical companies to test combinations of cancer-fighting drugs. That same year, he met with then-Vice President Joe Biden to discuss genomic sequencing of 100,000 cancer patients to build a global precision treatment database.
Media, Philanthropy, and Public Influence
After purchasing the Los Angeles Times in June of 2018, Soon-Shiong expanded his portfolio to include one of the most illustrious newspapers in the United States. Since 2010, he has been a minority owner of the Los Angeles Lakers. NantSA and NantAfrica are 2 of his charitable endeavors. In 2021, he collaborated with South African President Cyril Ramaphosa to launch these organizations, which have the objective of producing one billion doses of vaccines in sub-Saharan Africa.
Additionally, he is a supporter of the Access to Advanced Health Institute, which is a non-profit organization that focuses on research on infectious diseases and vaccines. His public profile, which encompasses medicine, technology, the media, and philanthropy, provides him with a platform that is significantly more extensive than what the majority of pharmaceutical executives command. Exactly because of this reach, the warning that the FDA issued in March 2026 carries consequences that go far beyond those of a typical regulatory letter.
Disclaimer: This information is not intended to be a substitute for professional medical advice, diagnosis or treatment and is for information only. Always seek the advice of your physician or another qualified health provider with any questions about your medical condition and/or current medication. Do not disregard professional medical advice or delay seeking advice or treatment because of something you have read here.
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