ImmunityBio submitted a response to FDA OPDP regarding ANKTIVA promotional materials, outlining corrective actions, removal of a podcast, and confirmation that a cited TV advertisement was never aired.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
ImmunityBio, Inc. announced that it has submitted a comprehensive response to the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) regarding concerns raised on March 13, 2026 about a television advertisement and a podcast related to ANKTIVA® (nogapendekin alfa inbakicept-pmln). The company stated that it addressed the issues associated with the podcast and clarified that the referenced television advertisement was never aired.
According to the company, the response outlines immediate and planned corrective actions and reiterates its commitment to ensuring that promotional communications for ANKTIVA are accurate, balanced, and compliant with FDA regulations.
ImmunityBio reported that it removed the identified podcast from its corporate website and requested removal from third-party platforms. The company also confirmed that the television advertisement cited by OPDP was not broadcast or disseminated to the public.
ImmunityBio President and CEO Richard Adcock stated that the company treats promotional compliance as a priority and aims to clearly distinguish between investigational pipeline discussions and approved indications. He indicated that the company believes its remedial actions and strengthened internal procedures address the agency’s concerns.
Following receipt of the OPDP letter, ImmunityBio initiated a review of promotional materials and external communications with its legal and regulatory teams. The company is implementing additional compliance measures, including mandatory executive training, expanded Promotional Review Committee protocols, and engagement of external regulatory counsel to audit future high-visibility communications.
In its response, ImmunityBio also provided context regarding statements cited by OPDP that were made during a podcast appearance by Founder and Executive Chairman Dr. Patrick Soon-Shiong. The company said the remarks reflected forward-looking views on the development pipeline and scientific strategy rather than promotional claims.
ImmunityBio further noted that characterization of the IL-15 platform as promising referenced an independent assessment by the National Cancer Institute, and that discussions of “cancer vaccines” referred to the mechanistic potential of immunotherapies designed to induce memory T-cell responses.
ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex designed to activate natural killer (NK) cells and CD8+ T cells. The therapy consists of an IL-15 mutant fused with IL-15 receptor alpha, enabling high-affinity binding to immune cells and promoting activation, proliferation, and immune memory. The company states this mechanism aims to enhance immune responses against tumor cells and support durable anti-cancer activity.
Reference
ImmunityBio Addresses FDA Correspondence and Reaffirms Commitment to Advertising Compliance, 06 April 2026, ImmunityBio Addresses FDA Correspondence and Reaffirms Commitment to Advertising Compliance – ImmunityBio
About the Writer
Vennela Reddy, BPharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.