FDA Warns ImmunityBio Over 'False and Misleading' Anktiva Ads Featuring CEO Patrick Soon-Shiong

By FieldPulse Editorial · March 24, 2026

Tags: FDA, Compliance, Oncology

The FDA has issued a warning letter to ImmunityBio and its founder Patrick Soon-Shiong over TV ads and podcast appearances that the agency said made false and misleading claims about Anktiva, a bladder cancer drug.

The FDA issued a warning letter to ImmunityBio and its founder and executive chairman Patrick Soon-Shiong on Monday, citing what the agency described as false and misleading promotional claims about Anktiva — the company's bladder cancer drug known generically as nogapendekin alfa inbakicept-pmln.

According to the agency, the violations appeared in television advertisements and in podcast appearances made by Soon-Shiong himself.

The FDA found that the promotional materials overstated the drug's efficacy and minimized its associated risks — two of the most serious categories of promotional violation the agency pursues through its Office of Prescription Drug Promotion.

Anktiva is approved for a specific indication in non-muscle-invasive bladder cancer, and like all prescription drugs, its promotion must stay within the bounds of the approved labeling.

When promotional claims — whether in paid advertising or public appearances by company leadership — go beyond what the data support or downplay risk information, the FDA has enforcement tools to push back, with warning letters being among the most formal and publicly visible.

The involvement of Soon-Shiong, one of the most prominent and media-savvy executives in biotech, makes this case unusual.

Founder-led companies sometimes struggle with the line between legitimate disease awareness advocacy and regulated drug promotion, particularly when a charismatic CEO is a public figure with direct media access.

The FDA's decision to name Soon-Shiong personally in the warning letter is notable.

For pharma and biotech sales reps, this case is a useful reminder about how tightly promotional compliance standards are applied — and how enforcement applies to all channels, not just traditional sales materials.

In an era when executives routinely appear on podcasts, social media, and television to discuss their companies' drugs, the regulatory perimeter around promotion extends into those formats as well.

ImmunityBio will be required to.

Source: https://www.statnews.com/