ImmunityBio Founder Disputes FDA Warning Over Anktiva Claims

Patrick Soon-Shiong says TV ad referenced in letter 'never aired at all'

Apr. 14, 2026 at 2:35am

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A photorealistic studio photograph of a single glass vial filled with a glowing blue liquid, representing the Anktiva cancer therapy, floating elegantly on a clean, white background with dramatic lighting and deep shadows to convey the abstract concepts of regulatory oversight and scientific innovation.A photographic still life captures the regulatory tensions surrounding the marketing of a novel cancer immunotherapy.Boston Today

ImmunityBio founder Patrick Soon-Shiong pushed back against a recent FDA warning letter over promotional claims for the company's cancer therapy Anktiva, stating that a referenced TV ad 'never aired at all' and that the agency classified his podcast appearance as 'promotional speech' rather than scientific commentary.

Why it matters

The FDA warning letter cited both a TV ad and Soon-Shiong's podcast appearance as examples of misleading promotional language suggesting uses beyond Anktiva's approved indication for certain bladder cancer patients. This highlights the regulatory tension between scientific discussion and marketing for approved therapies, which Soon-Shiong says creates a 'real tension between the First Amendment of free speech and the FDA's policy of what they call promotional speech.'

The details

The FDA warning letter referenced both a television advertisement and Soon-Shiong's earlier January appearance on The Sean Spicer Show as examples of promotional language suggesting uses beyond Anktiva's approved indication for BCG-unresponsive non-muscle-invasive bladder cancer. Soon-Shiong said the agency classified the podcast discussion as direct-to-consumer 'promotional speech' rather than scientific commentary. He added that regulators referenced only a transcript submitted as part of routine promotional review procedures, rather than a broadcast commercial, and that 'the potential transcript of that ad never aired at all.'

  • The FDA warning letter was issued last month.
  • Soon-Shiong appeared on The Sean Spicer Show in January.

The players

Patrick Soon-Shiong

Founder of ImmunityBio, Inc. (IBRX), a biotechnology company focused on cancer and infectious disease therapies.

Anktiva

An IL-15-based immunotherapy approved along with BCG for certain patients with non-muscle invasive bladder cancer that no longer responds to standard therapy.

FDA

The U.S. Food and Drug Administration, the federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

The Sean Spicer Show

A podcast hosted by former White House Press Secretary Sean Spicer.

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What they’re saying

“The warning letter related to two things, one, a TV ad and two, the Sean Spicer podcast. The TV ad, as it turned out, we never had the TV ad.”

— Patrick Soon-Shiong, Founder, ImmunityBio

“The potential transcript of that ad never aired at all.”

— Patrick Soon-Shiong, Founder, ImmunityBio

“The issue really was that they considered my podcast with you a promotional speech, which then fell under very strict FDA rules.”

— Patrick Soon-Shiong, Founder, ImmunityBio

What’s next

ImmunityBio has submitted a formal response to regulators outlining compliance steps, including enhanced promotional-review protocols, executive training and external regulatory oversight.

The takeaway

This case highlights the delicate balance biotechnology companies must strike between scientific discourse and regulatory oversight when promoting approved therapies. It underscores the need for clear communication and transparency around promotional activities to avoid potential conflicts with the FDA.