FDA flags misleading claims for cancer drug by biotech billionaire Patrick Soon-Shiong
WASHINGTON– Federal health officials issued a warning Tuesday regarding misleading statements made by biotech billionaire Dr. Patrick Soon-Shiong, who recently told podcast listeners that his company’s bladder cancer drug may be able to treat, cure or even prevent other types of cancer.
The Food and Drug Administration’s warning letter takes issue with a television ad and a separate podcast episode promoting Anktiva, the flagship product of ImmunityBio Inc. The drugmaker is one of several biotechnology companies acquired by Soon-Shiong, who also owns the Los Angeles Times.
The company’s shares fell more than 24% in trading Tuesday after the FDA warning was posted online.
Anktiva was approved by the FDA in 2024 for patients with a difficult-to-treat form of bladder cancer. ImmunityBio has been working to gain FDA approval to expand the drug’s use to a number of other conditions, including certain 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 in the interview, Soon-Shiong described his company’s drug as “the most important molecule that could cure cancer.” Minutes later, Soon-Shiong – the company’s executive chairman and chief medical officer – said that while the drug is approved for bladder cancer, “it can actually treat all cancers.”
Later in the episode, he said, “We have a treatment to prevent cancer if you’re exposed to radiation, and it’s Anktiva.” »
FDA regulators said the statements violated federal drug marketing rules because they “create a misleading impression” of the drug.
Regulators also noted that the podcast contained no information about the drug’s risks and side effects, which can include urinary tract infections, pain, chills and fever. Under FDA law, drug promotion must provide a balanced view of a drug’s risks and benefits.
The FDA warning, addressed to ImmunityBio CEO Richard Adcock, raises similar concerns about a television commercial for Anktiva. The ad and podcast refer to the company’s drug as a “cancer vaccine,” which the FDA says is false.
The FDA letter gives the company 15 days to correct the problems and respond in writing to the agency about its plans. As of Tuesday afternoon, a link to the podcast had been removed from ImmunityBio’s website.
Sarah Singleton, a spokeswoman for ImmunityBio, based in Culver City, Calif., said by email that the company takes the FDA warning “very seriously” and plans to “work cooperatively with the agency to address the issues raised in the letter.”
Under the Trump administration, the FDA has increased warnings against drugmakers as well as online pharmacies, including appearances by company executives on television shows and podcasts.
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