FDA Objects to Claims by Soon-Shiong on Cancer Drug

Federal health officials have posted a warning about misleading statements made by biotech billionaire 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 warning letter from the Food and Drug Administration on Tuesday takes issue with a TV advertisement and a podcast episode promoting Anktiva, the lead product of ImmunityBio Inc., the AP reports. The California-based drugmaker is one of several biotech firms acquired by Soon-Shiong, who also owns the Los Angeles Times.

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 statements came during a January episode of the Sean Spicer Show podcast entitled "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." Still later, 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 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 law, drug promotions are required to give a balanced view of a drug's risks and benefits. The FDA warning, addressed to CEO Richard Adcock, raises similar concerns about a TV advertisement for Anktiva. Both the ad and the podcast refer to the company's drug as a "cancer vaccine," which the FDA said is false. The letter gives the company 15 days to correct the problems. By Tuesday afternoon, a link to the podcast had been removed from ImmunityBio's website. A spokesperson for ImmunityBio said via email that the company plans to "work cooperatively with the agency to address the matters raised."