Patrick Soon-Shiong's ANKTIVA Claims Are Spreading Fast on Social Media — Here's What the FDA Itself Said

Updated October 20, 2026: On October 14, 2026, the FDA expanded the approved use of ANKTIVA. It is still given with BCG. It now covers adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. It also covers adults with high-grade, papillary-only disease that has not spread into the bladder muscle and has not responded to BCG. The expanded approval rests on the same 77-patient CIS trial, which had no comparison group. It does not cover any other cancer. See what the expansion covers and our plain-language explainer.

Dr. Patrick Soon-Shiong is a surgeon-entrepreneur and the developer of ANKTIVA. He has become the subject of a wave of Instagram posts, from accounts including wellthivo and lifespancode. These posts make increasingly dramatic claims. They say low lymphocyte counts, not tumors, are the "real killer" in cancer. They say ANKTIVA has shrunk brain tumors in patients who'd exhausted every other option. They give detailed explanations of the IL-15 immune mechanism behind the drug.

Cancer Explained doesn't have to weigh in alone here. The FDA already has. On March 13, 2026, the FDA's Office of Prescription Drug Promotion sent Dr. Soon-Shiong's own company, ImmunityBio, a formal warning letter. It concerned a podcast and a TV ad making very similar claims about ANKTIVA. That letter is worth reading directly against what's circulating on social media now.

We've covered ImmunityBio and ANKTIVA's approved-versus-promotional claims before, from a different angle. See What Patrick Soon-Shiong's ImmunityBio Has Actually Proven in Cancer Treatment for the underlying trial data behind the FDA-approved bladder cancer use. This page focuses specifically on the FDA's own warning letter and what it says about the wider claims spreading on social media.

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What's FDA-approved, and confirmed

ANKTIVA (nogapendekin alfa inbakicept) is real and FDA-approved. But its approved use is narrow and limited to bladder cancer. It was first approved in 2024 for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS). On October 14, 2026, the FDA expanded the approval to also include adults with high-grade, papillary-only BCG-unresponsive disease. Both uses are for bladder cancer that has not grown into the bladder muscle. It's given intravesically, meaning directly into the bladder, alongside BCG immunotherapy. The underlying immunology described in these posts is also broadly accurate. IL-15 is a real cytokine that activates natural killer (NK) cells and CD8+ T cells. ANKTIVA is engineered to mimic and prolong that signal. Absolute Lymphocyte Count (ALC) is a real, clinically used blood marker. Published research does link severe lymphopenia, meaning a low ALC, to worse outcomes in some cancers.

What the FDA's warning letter actually found

The FDA's letter to ImmunityBio quotes Dr. Soon-Shiong directly from a podcast and a TV ad. It then states plainly why each claim is false or misleading. The FDA cited several claims:

• That ANKTIVA "can treat all cancers."
• That it is "the most important molecule" that could, in the posts' framing, change cancer treatment.
• That it can prevent cancer after radiation exposure.
• That it can "treat the tumor, and it doesn't come back."

The FDA's response is direct: "Anktiva is not approved as a treatment for 'all cancers' or lung cancer after failure of checkpoint inhibitors, nor is it approved for any form of cancer prevention." It adds: "Anktiva is not a vaccine."

The letter also lays out the actual trial data behind the approval. The QUILT-3.032 study of 77 patients found a 62% complete response rate. But only 58% of those responses lasted 12 months. Just 40% lasted 24 months. The trial had no comparator arm. Because of that, the FDA states any claim about long-term durability, or "it doesn't come back," is not supported by the data. The ad in question also showed the drug being given by injection. It is approved only for intravesical use. That means it is placed directly into the bladder.

Where the social media claims outrun the evidence

The brain tumor shrinkage described in one Instagram post is explicitly anecdotal. It's an individual clinical observation. It is not a completed, published, peer-reviewed clinical trial. It is not an FDA-approved use of the drug.

Some posts frame it this way: "cancer is not the disease, it's the symptom" of immune collapse. They suggest that checking one lab value, ALC, tells a family "whether the body still has anything left to fight with." This oversimplifies a genuinely complex, multi-factor disease process into a single number and a single drug. The claim that "99% of doctors do not look at" ALC is also not accurate. It's part of the standard complete blood count with differential. Oncologists often review it, particularly for patients on chemotherapy or immunotherapy,.

Why this matters

A federal regulator has reviewed claims strikingly similar to those spreading on Instagram. It concluded, in writing, that they overstate what trial data show. Off-label anecdotal use of an approved drug is real in medicine. But it differs meaningfully from FDA-approved, trial-proven use. A drug's own developer describing it favorably on a podcast is a different kind of source than an independent regulator's review of the same evidence.

What to do with this information

If you or someone you love has a cancer type not covered by ANKTIVA's approval, ask your own oncologist a direct question. Is IL-15-based immunotherapy being studied for your specific situation in a registered clinical trial? That's the legitimate path to accessing emerging treatments safely, rather than acting on a podcast anecdote. For bladder cancer patients who haven't responded to BCG, ANKTIVA is a real, approved option worth discussing directly.

How this article was prepared

An AI-assisted editorial system helped prepare this page based on the FDA's approval announcement for ANKTIVA, the FDA's March 13, 2026 warning letter to ImmunityBio, Inc., and the original social media posts. No named medical reviewer has reviewed it unless one is listed.

Cancer Explained is published by the National Cancer Information Foundation. It is not medical advice and does not suggest a test or treatment.

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