The U.S. Food and Drug Administration (FDA) issued a warning to ImmunityBio, stating that the company's claims about its cancer drug Anktiva are misleading. The FDA reviewed an advertisement and a podcast episode featuring ImmunityBio's executive chairman, Dr. Patrick Soon-Shiong, who suggested the drug could treat, cure, or even prevent all cancers. The FDA determined these statements violate federal drug marketing rules and create a misleading impression about Anktiva's capabilities.
Anktiva is currently approved for treating a specific form of bladder cancer. The FDA's warning letter, issued on March 13, 2024, noted that the drug is not approved for other uses, including lung and pancreatic cancer, which were mentioned in the promotional materials. The letter also highlighted that the drug's labeling does not provide adequate directions for these unapproved uses.
Following the FDA's warning, ImmunityBio's shares fell more than 21% in trading. The company has been working to expand Anktiva's approval to other conditions, but the FDA's action raises questions about the regulatory hurdles ahead. Dr. Soon-Shiong, a billionaire biotech investor, has been a vocal advocate for the drug's potential, describing it as 'the most important molecule that could cure cancer' in the podcast episode.