ImmunityBio Addresses FDA OPDP Concerns, Strengthens Compliance And Clarifies ANKTIVA Promotional Communications

ImmunityBio, Inc. has submitted a detailed response to the U.S. Food and Drug Administration Office of Prescription Drug Promotion regarding concerns raised in March 2026 about certain promotional materials, including a podcast and a television advertisement. The company clarified that the television ad in question was never aired, while addressing issues related to the podcast content.

As part of its response, ImmunityBio outlined both immediate and long-term corrective measures to ensure compliance with regulatory standards. These steps include removing the podcast from its website, requesting its deletion from third-party platforms, and conducting a comprehensive internal review of all promotional materials in collaboration with legal and regulatory teams.

“ImmunityBio takes promotional compliance with the utmost seriousness,” said Richard Adcock, President and CEO of ImmunityBio. “We are dedicated to maintaining a clear distinction between our investigational pipeline aspirations and the promoted indications for our approved therapies. We believe our substantive remedial actions and enhanced internal protocols address the Agency’s concerns.”

The company also announced enhancements to its compliance framework, such as mandatory executive training, expanded Promotional Review Committee protocols, and the involvement of external regulatory experts to audit future communications. These actions reflect ImmunityBio’s commitment to maintaining accuracy, balance, and adherence to FDA guidelines in all promotional activities related to ANKTIVA®.

In addition, ImmunityBio provided context for statements made during a podcast by its founder, Patrick Soon-Shiong, emphasizing that the remarks were forward-looking and reflected scientific perspectives on its immunotherapy pipeline. The company highlighted that references to IL-15 and “cancer vaccines” were grounded in prior scientific evaluations, including assessments by the National Cancer Institute, and were intended to describe the broader potential of its research strategy.