Immunotherapy company ImmunityBio has formally responded to the US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) regarding a March 13 letter about a television advertisement and a podcast.

 

The company confirmed the TV ad was never aired and has taken steps to remove the podcast from its website and third-party platforms.

 

The submission outlines ImmunityBio’s immediate and planned corrective actions, emphasizing its commitment to accurate and compliant promotion of ANKTIVA (nogapendekin alfa inbakicept-pmln).

 

“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.”

 

Following receipt of the OPDP letter, ImmunityBio launched a full review of all promotional materials with its legal and regulatory teams. The company is implementing a robust suite of corrective measures, including mandatory executive training, expanded Promotional Review Committee (PRC) oversight, and engagement of external regulatory counsel to audit future high-profile communications.