FDA Flags Misleading Claims on Cancer Drug Made by Billionaire Owner of ImmunityBio

Federal health officials issued a warning Tuesday over misleading statements made by biotech billionaire Patrick Soon-Shiong, MD, who recently told podcast listeners that his company’s bladder cancer drug may be able to treat, cure, or even prevent other types of cancers.

The warning letter from the FDA takes issue with a TV advertisement and a separate podcast episode promoting nogapendekin alfa inbakicept (Anktiva), the lead product of ImmunityBio. The drugmaker is one of several biotech firms acquired by Soon-Shiong, who also owns the Los Angeles Times.

Company shares fell more than 24% in trading Tuesday after the FDA warning posted online.

Anktiva was approved by the FDA in 2024 for patients with bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer. ImmunityBio has been working to win FDA approval to expand the drug’s use to a number of other conditions, including forms of lung and pancreatic cancer.

Soon-Shiong’s controversial statements came during a January episode of “The Sean Spicer Show” podcast titled: “Is the FDA blocking life-saving cancer treatments?”

At one point during the interview, Soon-Shiong described his company’s drug as “the most important molecule that could cure cancer.” A few minutes later, Soon-Shiong — who is the company’s executive chairman and chief medical officer — said that while the drug is approved for bladder cancer, “it actually can treat all cancers.”

Later in the episode he said: “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.”

FDA regulators said the statements violate federal drug marketing rules because they “create a misleading impression” of the drug.

Regulators also noted that the podcast didn’t contain any information about risks and side effects of the drug, which can include urinary tract infections, pain, chills, and pyrexia. Under FDA law, drug promotions are required to give a balanced view of a drug’s risks and benefits.

The FDA warning, addressed to ImmunityBio CEO Richard Adcock, raises similar concerns with a TV advertisement for nogapendekin alfa inbakicept, an interleukin 15 receptor agonist. Both the ad and the podcast refer to the company’s drug as a “cancer vaccine,” which the FDA said is false.

The FDA letter gives the company 15 days to correct the problems and respond to the agency in writing about its plans. By Tuesday afternoon, a link to the podcast had been removed from ImmunityBio’s website.

Sarah Singleton, spokesperson for Culver City, California-based ImmunityBio, said via email that the company takes the FDA’s warning “very seriously,” and plans to “work cooperatively with the agency to address the matters raised in the letter.”

Under the Trump administration, the FDA has stepped up warnings against drugmakers as well as online pharmacies, including appearances by company executives on TV shows and podcasts.

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