> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ImmunityBio Responds to FDA Concerns Over Promotional Materials
- URL: https://www.fdaweb.com/immunitybio-responds-to-fda-concerns-over-promotional-materials/
- Published: 2026-04-06T12:00:00.000Z
- Updated: 2026-09-14T13:36:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160935

ImmunityBio says it has responded to FDA’s recent Warning Letter on the company’s alleged misleading promotional claims about its cancer therapy Anktiva (nogapendekin alfa inbakicept-pmln) in both a television advertisement and a podcast appearance by company leadership ([see earlier story](https://www.fdaweb.com/immunitybio-warning-letter-over-misleading-promotion-of-anktiva/)). The company says it is taking steps to strengthen its advertising compliance practices following agency concerns. tied to a podcast and a television advertisement.

As part of its response, ImmunityBio says it has removed the podcast cited by regulators from its Web site and requested its removal from third-party platforms. The company also clarifies that the television advertisement referenced in the FDA letter was never aired or disseminated to the public.

The Culver City–based firm says it has initiated a comprehensive internal review of its promotional materials and is implementing enhanced compliance measures. These include expanded review protocols for marketing content, mandatory executive training, and the use of external regulatory advisors to audit high-profile communications.

ImmunityBio notes that the issues raised by regulators stemmed in part from comments made during a podcast appearance by its founder and executive chairman, **Patrick Soon-Shiong**. According to the company, those remarks were intended as forward-looking views on its research pipeline and broader scientific strategy, rather than promotional claims about approved products.

The company emphasized that references to emerging cancer treatments and so-called “cancer vaccines” were meant to describe investigational approaches involving immune system activation, including therapies designed to generate long-term immune memory.

Anktiva, an interleukin-15–based immunotherapy, is designed to stimulate natural killer cells and T cells to target cancer. ImmunityBio says it remains committed to ensuring that all communications about the therapy align with FDA requirements as it continues to commercialize the product and advance its broader pipeline.