WASHINGTON — Federal health officials issued a warning regarding misleading statements made by biotech billionaire Dr. Patrick Soon-Shiong, who claimed in a podcast that Anktiva, his company’s bladder cancer drug, could treat, cure, or prevent other forms of cancers. The warning from the Food and Drug Administration (FDA) criticized both a TV advertisement and the podcast episode promoting Anktiva, which is developed by ImmunityBio Inc., a company that Soon-Shiong acquired. Following the FDA warning, shares of ImmunityBio plummeted by over 24%. Anktiva received FDA approval in 2024 for a hard-to-treat type of bladder cancer, and the company is currently pursuing approval for additional uses, including lung and pancreatic cancers. Soon-Shiong’s comments, made during an episode of The Sean Spicer Show titled Is the FDA blocking life-saving cancer treatments?, raised eyebrows as he described Anktiva as potentially being the most important molecule that could cure cancer. Specifically, he mentioned the drug’s capabilities in relating to various cancers later in the discussion. The FDA indicated that such statements violate marketing regulations as they create a misleading perception of the drug's abilities. Furthermore, the podcast omitted critical information about the drug's risks and side effects, which can include urinary tract infections and fever. Under FDA law, drug promotions are mandated to present a balanced view of the benefits and risks associated with pharmaceuticals. In the warning letter to ImmunityBio CEO Richard Adcock, the FDA highlighted its concerns regarding both the podcast and the TV ad, both referring to the drug inaccurately as a “cancer vaccine.” The agency has granted ImmunityBio 15 days to amend the issues noted in the letter, and in response to the fallout, a link to the podcast has already been removed from the company’s website. A spokesperson for ImmunityBio stated that the company intends to cooperate with the FDA to rectify the situation. The FDA has recently become stricter about regulating drug marketing, necessitating transparency from pharmaceutical companies, especially after increasing appearances by company executives in media discussions.
FDA Issues Warning Over Misleading Cancer Drug Claims by Dr. Patrick Soon-Shiong
The FDA warns Dr. Patrick Soon-Shiong of ImmunityBio regarding misleading claims made about Anktiva, a drug approved for bladder cancer, suggesting it could treat other forms of cancer.
Regulatory scrutiny is intensifying around biotech billionaire Dr. Patrick Soon-Shiong after the FDA issued a warning concerning misleading statements about Anktiva, an FDA-approved bladder cancer drug. The warning cites promotional claims suggesting the drug could cure all cancers, which the agency deems misleading and lacking required risk disclosures. As a result, ImmunityBio's stock saw a significant decline in value. The company has been given 15 days to address the concerns outlined in the FDA's correspondence.
