The US Food and Drug Administration (FDA) has issued a warning to biotech billionaire Dr Patrick Soon-Shiong over misleading claims about his company's bladder cancer drug, Anktiva. The warning, published on Tuesday, takes issue with statements made during a podcast and a television advertisement that the regulator says create a misleading impression of the drug's capabilities.
During an episode of The Sean Spicer Show podcast in January, Soon-Shiong, who is executive chairman and chief medical officer of ImmunityBio Inc, described Anktiva as "the most important molecule that could cure cancer" and claimed it "actually can treat all cancers". He also suggested the drug could prevent cancer in those exposed to radiation. The FDA said these statements violate federal drug marketing rules.
Anktiva was approved by the FDA in 2024 for patients with a hard-to-treat form of bladder cancer. ImmunityBio has been seeking approval to expand its use to other conditions, including lung and pancreatic cancer. However, the FDA noted that the podcast failed to mention the drug's risks and side effects, which include urinary tract infections, pain, chills and fever.
The FDA also criticised a television advertisement that referred to Anktiva as a "cancer vaccine", which the regulator said is false. The warning letter, addressed to ImmunityBio CEO Richard Adcock, gives the company 15 days to correct the issues and respond in writing. By Tuesday afternoon, a link to the podcast had been removed from ImmunityBio's website.
Shares in ImmunityBio fell more than 24% following the warning. Company spokesperson Sarah Singleton said the firm takes the FDA's warning "very seriously" and plans to work cooperatively with the agency. The FDA has increased scrutiny of drugmakers' promotional activities under the Trump administration.
