FDA Issues Warning Letter to ImmunityBio Over Misleading Claims About Anktiva

The U.S. Food and Drug Administration (FDA) issued a warning letter to ImmunityBio regarding promotional statements about its cancer drug, Anktiva. The letter, dated March 13, 2026, marks the first formal warning from the FDA's Office of Prescription Drug Promotion (OPDP) this year. It follows previous untitled letters sent to ImmunityBio, which raised similar concerns about the marketing of Anktiva. The FDA's warning highlights misleading claims made in a television advertisement and a podcast episode featuring Dr. Patrick Soon-Shiong, the company's executive chairman, and CEO Richard Adcock.

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The FDA's letter specifically addresses statements made by Soon-Shiong, who claimed that Anktiva could treat all cancers and prevent cancer after radiation exposure. These assertions are misleading, as Anktiva is only FDA-approved for a specific type of bladder cancer. The promotional materials also failed to adequately present risk information and did not include the drug's full FDA-approved indication. The FDA has mandated that ImmunityBio respond within 15 days, either by justifying the promotional content or outlining a plan to correct the misleading statements.

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Following the release of the FDA's warning letter, ImmunityBio's stock experienced a significant decline, dropping approximately 24% from over $9 to below $7. In response to the FDA's concerns, ImmunityBio issued a statement acknowledging receipt of the warning letter and expressing its commitment to regulatory compliance. The company stated, “We take the FDA’s concerns seriously and have initiated a review of the letter with our legal and regulatory teams.”

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The FDA's action reflects a broader trend of increased scrutiny and enforcement against pharmaceutical companies regarding marketing practices. The agency has emphasized the importance of balanced information in drug promotions, which must include both benefits and risks. This warning to ImmunityBio underscores the regulatory challenges faced by biotech companies, particularly those led by high-profile figures like Soon-Shiong, who also owns the Los Angeles Times.

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ImmunityBio has committed to working cooperatively with the FDA to address the issues raised in the warning letter. The company stated, “We are committed to maintaining the highest standards for scientific accuracy and regulatory compliance.”

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• “We take the FDA’s concerns seriously and have initiated a review of the letter with our legal and regulatory teams.” — ImmunityBio

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• “it actually can treat all cancers.” — Dr. Patrick Soon-Shiong

Biotech Billionaire Gets FDA Warning Over Cancer Drug Claims

• “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.” — Dr. Patrick Soon-Shiong

Biotech Billionaire Gets FDA Warning Over Cancer Drug Claims

While the FDA's letter outlines specific misleading claims, it does not detail the full scope of potential consequences for ImmunityBio. Additionally, the company is actively seeking regulatory approval for Anktiva's use in other cancer types, which may complicate the narrative surrounding its marketing practices.

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This situation highlights the ongoing challenges in the biotech industry regarding compliance with federal regulations and the implications of public statements made by company executives.

Biotech Billionaire Gets FDA Warning Over Cancer Drug Claims