WASHINGTON (AP) — 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 could treat, cure, or even prevent other types of cancers.
The warning letter from the Food and Drug Administration criticizes a TV advertisement and a separate podcast episode promoting Anktiva, the lead product of ImmunityBio Inc. Soon-Shiong, who also owns the Los Angeles Times, has faced scrutiny over these claims.
Following the FDA warning, shares of ImmunityBio fell by more than 24%. Anktiva was approved by the FDA in 2024 for patients with a hard-to-treat form of bladder cancer, and the company is seeking to expand its usage to lung and pancreatic cancers.
During a January episode of The Sean Spicer Show, Soon-Shiong referred to Anktiva as “the most important molecule that could cure cancer” and later stated that it “can treat all cancers.” He also claimed it could prevent cancer after radiation exposure.
The FDA contends such statements violate federal drug marketing regulations, as they mislead the public regarding the drug’s efficacy. The podcast did not provide any information on risks and side effects, which can include urinary tract infections and other complications.
In its letter to ImmunityBio CEO Richard Adcock, the FDA outlined similar concerns regarding the TV advertisement calling Anktiva a “cancer vaccine,” deemed false by the agency. The FDA has given the company 15 days to rectify these issues.
Sarah Singleton, a spokesperson for ImmunityBio, stated the company would take the FDA’s warning seriously and work cooperatively to address the agency's concerns. Under the Trump administration, the FDA has intensified oversight on drug marketing, particularly concerning claims made by drug makers.
