FDA Warns ImmunityBio Over Misleading Cancer Drug Claims

Regulators object to CEO's statements about Anktiva's capabilities on podcast and in TV ad

Mar. 26, 2026 at 2:00am

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The U.S. Food and Drug Administration has issued a warning letter to ImmunityBio, a biotech firm owned by billionaire Patrick Soon-Shiong, over misleading claims made about the company's bladder cancer drug Anktiva. The FDA took issue with statements Soon-Shiong made on a podcast and in a TV ad, where he suggested the drug could treat, cure or even prevent other types of cancer, despite the drug only being approved for a specific form of bladder cancer.

Why it matters

The FDA's warning highlights the importance of drug companies making accurate and balanced claims about their products' capabilities, as misleading marketing can raise false hopes and lead to improper use of medications. This case also underscores the regulatory scrutiny biotech firms face as they seek to expand the uses of their approved drugs.

The details

In a January episode of the Sean Spicer Show podcast, Soon-Shiong described Anktiva as "the most important molecule that could cure cancer" and claimed "it actually can treat all cancers." He also said the drug could "prevent cancer if you were exposed to radiation." However, Anktiva is only approved by the FDA for treating a specific form of bladder cancer. The FDA said these statements "create a misleading impression" about the drug's capabilities and violate federal marketing rules, which require drug promotions to provide a balanced view of risks and benefits.

  • The FDA warning letter was issued on March 26, 2026.
  • Anktiva was approved by the FDA in 2024 for patients with a hard-to-treat form of bladder cancer.
  • Soon-Shiong made the misleading claims about Anktiva during a January 2026 episode of the Sean Spicer Show podcast.

The players

Patrick Soon-Shiong

A biotech billionaire who is the executive chairman and chief medical officer of ImmunityBio, the company that makes the bladder cancer drug Anktiva.

ImmunityBio Inc.

A California-based biotech firm that is one of several companies acquired by Patrick Soon-Shiong. ImmunityBio is the maker of the bladder cancer drug Anktiva.

Food and Drug Administration (FDA)

The U.S. federal agency responsible for regulating and supervising the safety of food, drugs, and other products. The FDA issued the warning letter to ImmunityBio over misleading claims about Anktiva.

Richard Adcock

The CEO of ImmunityBio, the company that received the FDA warning letter.

Sean Spicer

The host of the podcast where Patrick Soon-Shiong made the misleading claims about Anktiva.

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What they’re saying

“We have the therapy to prevent cancer if you were exposed to radiation, and that's Anktiva.”

— Patrick Soon-Shiong, Executive Chairman and Chief Medical Officer, ImmunityBio

“It actually can treat all cancers.”

— Patrick Soon-Shiong, Executive Chairman and Chief Medical Officer, ImmunityBio

“The most important molecule that could cure cancer.”

— Patrick Soon-Shiong, Executive Chairman and Chief Medical Officer, ImmunityBio

What’s next

The FDA has given ImmunityBio 15 days to correct the problems identified in the warning letter.

The takeaway

This case highlights the importance of drug companies making accurate and balanced claims about their products' capabilities, as misleading marketing can raise false hopes and lead to improper use of medications. The FDA's warning to ImmunityBio underscores the regulatory scrutiny biotech firms face as they seek to expand the uses of their approved drugs.