WASHINGTON (AP) 鈥� Federal health officials posted a warning Tuesday about misleading statements made by , 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 takes issue with a and a separate podcast episode promoting Anktiva, the lead product of ImmunityBio Inc. The drugmaker is one of several biotech firms acquired by Soon-Shiong, who also
Company shares fell more than 21% in trading Tuesday to close at $7.42 after the FDA letter posted online.
Anktiva was approved by the FDA in 2024 for patients with a hard-to-treat form of 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 鈥淭he Sean Spicer Show鈥� podcast titled 鈥淚s the FDA blocking life-saving cancer treatments?鈥�
At one point during the interview, Soon-Shiong described his company’s drug as 鈥渢he most important molecule that could cure cancer.鈥� A few minutes later, Soon-Shiong 鈥� who is the company’s executive chairman and chief medical officer 鈥� said that while the drug is approved for bladder cancer, 鈥渋t actually can treat all cancers.鈥�
Later in the episode he said, 鈥淲e have the therapy to prevent cancer if you were exposed to radiation, and that鈥檚 Anktiva.鈥�
FDA regulators said the statements violate federal drug marketing rules because they 鈥渃reate a misleading impression鈥� 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, 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 Anktiva. Both the ad and the podcast refer to the company’s drug as a 鈥渃ancer vaccine,鈥� which the FDA said is false.
The letter gives the company 15 days to correct the problems and respond to the agency in writing about its plans to comply. 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鈥檚 warning 鈥渧ery seriously,鈥� and plans to 鈥渨ork cooperatively with the agency to address the matters raised in the letter.鈥�
Under the Trump administration, the FDA has against drugmakers as well as online pharmacies, including appearances by company executives on TV shows and podcasts.
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