The U.S. Food and Drug Administration has issued a warning letter to ImmunityBio and its founder, Patrick Soon-Shiong, regarding promotional statements made about the cancer drug Anktiva.
According to regulators, comments made in a podcast and television advertisement suggested the drug could treat, cure, or even prevent multiple types of cancer—claims the FDA says are misleading and not supported by current approvals. While Anktiva received FDA approval in 2024 for a specific type of bladder cancer, it has not been approved for broader oncology use.
The agency emphasized that such statements violate federal drug marketing regulations by overstating the drug’s benefits and creating unrealistic expectations for patients. ImmunityBio is currently seeking expanded approvals for additional cancer types, including lung and pancreatic cancers, but those uses remain under review.
For healthcare providers and industry stakeholders, this action serves as a reminder of the strict requirements around drug promotion—particularly the need to clearly distinguish between approved uses and investigational or unproven claims.