The U.S. Food and Drug Administration (FDA) has warned a biotech company about claims that its bladder cancer drug could treat and prevent multiple types of cancer.
The agency sent a warning letter Tuesday to ImmunityBio, saying recent statements about its drug Anktiva were misleading.
The concerns involve comments made by its billionaire chairman, Dr. Patrick Soon-Shiong, during a January episode of "The Sean Spicer Show" podcast.
During the interview, Soon-Shiong, who also owns the Los Angeles Times, described the drug as "the most important molecule that could cure cancer." He also said that while Anktiva is approved for bladder cancer, "it actually can treat all cancers," The Associated Press reported.
At another point, he said, “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.”
FDA officials said those statements break federal marketing rules, because they “create a misleading impression” about what the drug can do.
Anktiva was approved in 2024 for patients with a hard-to-treat type of bladder cancer.
The company has been working to expand approval of the drug for other cancers, including lung and pancreatic cancer. But the FDA has not approved those uses.
Regulators also raised concerns about a TV ad and the podcast promo, both of which described the drug as a "cancer vaccine." The FDA said that claim is false.
The agency also noted that the podcast did not mention possible risks or side effects, which is required in drug promotion.
Side effects of the drug can include urinary tract infections, pain, chills and fever.
The FDA gave ImmunityBio 15 days to respond and explain how it will fix the issues, The Associated Press said.
A spokesperson for the company said it takes the warning “very seriously” and plans to “work cooperatively with the agency to address the matters raised in the letter.”
By Tuesday afternoon, the podcast link had been removed from ImmunityBio’s website.
The FDA has recently increased its review of drug promotions, including claims made by company leaders in interviews, TV appearances and podcasts.