Federal health officials on Tuesday warned ImmunityBio that marketing claims about its cancer drug Anktiva violated federal rules on drug promotion, including comments made by biotech billionaire Patrick Soon-Shiong on a podcast, the Food and Drug Administration said.
The FDA’s warning letter took issue with marketing materials that, regulators said, created a misleading impression about what the company’s drug could do. The letter was addressed to ImmunityBio CEO Richard Adcock and targeted both content tied to a television advertisement and separate podcast promotion, according to the FDA summary described by the Associated Press.
FDA officials said Soon-Shiong’s remarks appeared in a January episode of “The Sean Spicer Show” titled “Is the FDA blocking life-saving cancer treatments?” During the interview, Soon-Shiong described the drug as “the most important molecule that could cure cancer.” Minutes later, he said the drug, which is approved for bladder cancer, “it actually can treat all cancers,” according to the AP report.
Later in the episode, Soon-Shiong also said, “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva,” the AP reported. FDA regulators said the statements violated federal drug marketing rules because they “create a misleading impression” of Anktiva, which the FDA said is promoted beyond its approved scope.
The FDA also objected to how Anktiva was described as a “cancer vaccine.” Regulators said both the podcast and a television advertisement referred to the drug as a cancer vaccine, which the FDA said is false. The FDA also said the promotions did not provide information about risks and side effects that can include urinary tract infections, pain, chills and pyrexia.
The warning letter gave ImmunityBio 15 days to correct the problems and to respond to the agency in writing about its plans to comply, according to the AP. By Tuesday afternoon, a link to the podcast had been removed from ImmunityBio’s website, the report said.
ImmunityBio, based in Culver City, California, has said it takes the FDA’s concerns seriously. Sarah Singleton, a company spokesperson, told AP via email that the company was “very seriously” taking the warning and plans to “work cooperatively with the agency to address the matters raised in the letter.”
Anktiva was approved by the FDA in 2024 for patients with a hard-to-treat form of bladder cancer, the AP reported. ImmunityBio has been working to win FDA approval to expand the drug’s use to other conditions, including certain forms of lung and pancreatic cancer, according to the report.
The AP report also said the warning fits within a broader push by the Trump administration-era FDA to warn companies about drug promotions, including online pharmacies and appearances by company executives on television and podcasts.