FDA Criticizes Patrick Soon-Shiong’s Cancer Treatment Claims | STAT News

The Food and Drug Administration has issued a sharp warning to ImmunityBio, the biotechnology company founded and largely controlled by Patrick Soon-Shiong, over what the agency calls “false and misleading” claims made about its cancer treatment, Anktiva. The rebuke, delivered in a March 13 warning letter, centers on assertions made in television advertisements and a podcast suggesting the drug could treat “all cancers,” a claim far exceeding its approved use for a specific type of bladder cancer.

Anktiva’s Approved Use and the FDA’s Concerns

Anktiva, formally known as an interleukin-15 superagonist, received FDA approval in April 2024 to treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). As Fierce Pharma reported, this approval positioned Anktiva as a competitor to established treatments like Merck’s Keytruda and Ferring Pharmaceuticals’ Adstiladrin. However, the FDA’s warning letter indicates that ImmunityBio’s promotional materials significantly broadened this scope.

Beyond the overstated claims about treating “all cancers,” the FDA as well found fault with the omission of crucial information. Specifically, the agency noted that the advertising and podcast failed to adequately emphasize that Anktiva is intended to be used in combination with a BCG vaccine. The FDA stated that risks associated with the treatment were downplayed in the advertisement and entirely absent from the podcast. Perhaps most concerning, both promotional materials implied that patients treated with Anktiva would achieve a “cancer free” status, a result not substantiated by clinical trial data.

Understanding Anktiva and its Clinical Data

Anktiva’s development has been closely watched, particularly given Soon-Shiong’s high profile – he is a partial owner of the Los Angeles Lakers and owner of the Los Angeles Times. The drug works by stimulating the immune system to recognize and attack cancer cells. Clinical trial data, published in the Modern England Journal of Medicine Evidence in late 2022, showed promising results in a cohort of patients with high-risk NMIBC with CIS. According to the trial, 58 of 82 patients experienced no measurable tumors after a median follow-up of approximately two years, resulting in a 71% complete response rate with a median duration of 26.6 months.

Despite these positive findings, the FDA initially rejected Anktiva in May 2023, citing deficiencies discovered during a pre-approval inspection of ImmunityBio’s manufacturing facilities. The agency’s approval in April 2024 came after the company addressed those concerns. However, the recent warning letter suggests that the FDA remains vigilant regarding the accuracy of ImmunityBio’s promotional practices.

The Implications of Misleading Drug Promotion

Misleading drug promotion is a serious issue with potentially significant consequences for patient safety and public health. Exaggerated claims can lead patients to pursue treatments that are not appropriate for their condition, delay or forgo proven therapies, or experience unnecessary side effects. The FDA’s authority to issue warning letters is a key component of its oversight role, designed to ensure that pharmaceutical companies provide accurate and balanced information to healthcare professionals and the public.

The FDA’s warning to ImmunityBio underscores the importance of critically evaluating health information, particularly when it comes to cancer treatments. Patients should always discuss treatment options with their healthcare provider and rely on credible sources of information, such as the National Cancer Institute (https://www.cancer.gov/) and the American Cancer Society (https://www.cancer.org/), rather than solely on advertising or promotional materials.

What Happens Next: FDA Oversight and Company Response

The FDA’s warning letter requires ImmunityBio to promptly address the identified violations. The company must outline the steps it will take to correct the misleading claims and ensure future compliance with FDA regulations. The agency has the authority to take further action if ImmunityBio fails to adequately respond, including issuing fines, seeking injunctions, or even removing the drug from the market.

ImmunityBio has not yet publicly released a detailed response to the FDA’s warning letter as of March 24, 2026. However, the company is likely to revise its advertising and promotional materials to align with the FDA’s requirements. The FDA will continue to monitor ImmunityBio’s activities to ensure ongoing compliance. ImmunityBio’s website currently features discussions about Anktiva, including a recent presentation by Dr. Patrick Soon-Shiong at the 2024 AUA Annual Meeting, but it remains to be seen how these materials will be adjusted in light of the FDA’s concerns.

The situation with Anktiva serves as a reminder of the rigorous regulatory process governing drug approval and promotion in the United States. Even as innovation in cancer treatment is crucial, it must be balanced with a commitment to transparency, accuracy, and patient safety.