Federal health officials issued a warning Tuesday over 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 cancers. The warning letter from the Food and Drug Administration takes issue with a TV advertisement 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 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 a hard-to-treat form of bladder cancer. ImmunityBio has been working to win FDA approval to expand the drug’s use to multiple other conditions, including forms of lung and pancreatic cancer. Soon-Shiong's controversial statements emerged during a January episode of The Sean Spicer Show podcast, titled: Is the FDA blocking life-saving cancer treatments? He referred to his company’s drug as 'the most important molecule that could cure cancer,' and further stated that while the drug is approved for bladder cancer, 'it actually can treat all cancers.'
Later in the episode he added, 'We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.' The FDA's regulatory officials stated that these comments violated federal drug marketing rules as they 'create a misleading impression' of the drug. They also noted the podcast lacked information about the drug’s risks and side effects, which include urinary tract infections and chills. Under FDA law, drug promotions must provide a balanced view of drug 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 describe the drug as a 'cancer vaccine,' which the FDA stated is inaccurate. The FDA letter gives the company 15 days to rectify the outlined issues 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. A company spokesperson indicated they take the FDA’s warning 'very seriously' and will work closely with the agency to address the concerns raised. Under regulatory changes, the FDA has tightened warnings against drugmakers and online pharmacies, with increased scrutiny on executive promotional efforts.
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 multiple other conditions, including forms of lung and pancreatic cancer. Soon-Shiong's controversial statements emerged during a January episode of The Sean Spicer Show podcast, titled: Is the FDA blocking life-saving cancer treatments? He referred to his company’s drug as 'the most important molecule that could cure cancer,' and further stated that while the drug is approved for bladder cancer, 'it actually can treat all cancers.'
Later in the episode he added, 'We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.' The FDA's regulatory officials stated that these comments violated federal drug marketing rules as they 'create a misleading impression' of the drug. They also noted the podcast lacked information about the drug’s risks and side effects, which include urinary tract infections and chills. Under FDA law, drug promotions must provide a balanced view of drug 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 describe the drug as a 'cancer vaccine,' which the FDA stated is inaccurate. The FDA letter gives the company 15 days to rectify the outlined issues 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. A company spokesperson indicated they take the FDA’s warning 'very seriously' and will work closely with the agency to address the concerns raised. Under regulatory changes, the FDA has tightened warnings against drugmakers and online pharmacies, with increased scrutiny on executive promotional efforts.
