FDA Issues Stern Warning to ImmunityBio Over Misleading Cancer Drug Claims
WASHINGTON (AP) — Federal health officials have delivered a firm rebuke to biotech billionaire Dr. Patrick Soon-Shiong, citing “misleading statements” concerning his company ImmunityBio Inc.’s bladder cancer drug, Anktiva. The Food and Drug Administration (FDA) expressed significant concern over claims made in a podcast and a television advertisement suggesting the drug could treat, cure, or even prevent other forms of cancer. This development led to a sharp decline in ImmunityBio shares, which tumbled by over 24% in trading on Tuesday.
Dr. Soon-Shiong’s Controversial Statements
The warning letter, made public on Tuesday, specifically targets remarks made by Dr. Soon-Shiong, ImmunityBio’s executive chairman and chief medical officer, during a January episode of “The Sean Spicer Show” podcast. In the podcast, provocatively titled “Is the FDA blocking life-saving cancer treatments?”, Soon-Shiong made expansive assertions. He described Anktiva as “the most important molecule that could cure cancer” and claimed that despite its approval solely for bladder cancer, “it actually can treat all cancers.” He went further, suggesting the therapy could “prevent cancer if you were exposed to radiation.”
Discrepancy Between Approval and Promotion
Anktiva received FDA approval in 2024, but strictly for patients battling a particularly challenging form of bladder cancer. ImmunityBio has been actively seeking expanded FDA approval for the drug’s application across a spectrum of other cancers, including lung and pancreatic forms. However, the agency’s recent letter highlights a considerable disparity between the officially approved use and the public statements made by the company’s executive.
False “Cancer Vaccine” Claim and Omission of Risks
Beyond the exaggerated claims of broad efficacy, regulators emphasized that both the podcast and the TV advertisement referred to Anktiva as a “cancer vaccine,” a designation the FDA explicitly stated was false. Critically, neither promotional piece included any information about the drug’s potential risks and side effects. This omission is a significant violation of federal drug marketing regulations. Known side effects of Anktiva can include urinary tract infections, pain, chills, and pyrexia, underscoring the necessity for a balanced presentation of both benefits and risks in all drug promotions.
ImmunityBio’s Response and Broader Context
The FDA’s warning, addressed to ImmunityBio CEO Richard Adcock, demands that the company rectify these issues within 15 days and provide a written response outlining their corrective actions. Following the FDA’s intervention, a link to the contentious podcast episode was swiftly removed from ImmunityBio’s official website by Tuesday afternoon.
Sarah Singleton, a spokesperson for Culver City, California-based ImmunityBio, acknowledged the FDA’s warning via email, stating that the company takes the matter “very seriously” and intends to “work cooperatively with the agency to address the matters raised in the letter.”
This action by the FDA is consistent with a broader trend initiated under the Trump administration, which has seen an increase in warnings issued against drugmakers and online pharmacies. These warnings often target misleading promotional content, especially when company executives appear on television programs and podcasts, reinforcing the agency’s commitment to ensuring accurate and balanced information reaches the public about medical treatments.
Disclaimer
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
