A cancer drug gets a second act it never earned

Here is the pitch you may have scrolled past on X: a newly approved immunotherapy doesn't just fight cancer, it rejuvenates your immune system, and one billionaire physician-entrepreneur is calling it the most important longevity drug of the decade. The drug is Anktiva — generic name nogapendekin alfa inbakicept — and the man behind it is Patrick Soon-Shiong, founder of ImmunityBio and owner of the Los Angeles Times.1

The framing is seductive because it sits on top of something real. Anktiva is genuinely FDA-approved. It works through a mechanism that touches the exact immune cells that decline as we age. And the broader idea — that a failing immune system drives aging — is a legitimate, active area of research.10 So the leap from "approved cancer drug" to "longevity breakthrough" feels short. It is not. It is the entire distance between what the evidence shows and what the marketing claims, and that distance is where this newsletter lives.

I want to be precise from the first paragraph, because this is a case where being sloppy would be unfair to a real, useful medicine. Anktiva has earned its bladder-cancer approval. What it has not earned — what no human study has even attempted to give it — is the right to be called a longevity drug. Let's separate the two.

The approved use is real and evidence-based. The longevity claim rests on mechanism, analogy, and a stock price.

Dr. Maren Cole

An IL-15 superagonist, built to wake up killer cells

Anktiva is an interleukin-15 superagonist. Interleukin-15, or IL-15, is a signaling protein your body uses to grow and sustain two of the most aggressive players in your immune system: natural killer cells and CD8-positive cytotoxic T cells — the "killer" cells that hunt down virus-infected and cancerous cells.7 Native IL-15 is fragile, with a half-life measured in minutes. The engineers at ImmunityBio fused a mutated IL-15 to an IL-15 receptor-alpha fragment and an antibody scaffold, stretching the half-life to roughly twenty hours and mimicking the way the body naturally presents IL-15 to its target cells.8

The clever part is what it doesn't do. Older cytokine drugs like interleukin-2 expanded killer cells but also expanded regulatory T cells, the immune system's brakes, blunting the benefit. Anktiva preferentially expands the killers without the brakes.7 That selectivity is why it's the first new cytokine cancer therapy the FDA has approved in more than three decades.1

On April 22, 2024, the FDA approved Anktiva for a narrow, specific use: adults with BCG-unresponsive non-muscle-invasive bladder cancer that includes carcinoma in situ, given together with BCG, the old tuberculosis vaccine that has long been used to treat early bladder cancer.1 Note three things about that sentence. It is bladder cancer. It is given with BCG, not alone. And it is delivered intravesically — instilled directly into the bladder through a catheter, not injected into the bloodstream.3 Hold onto that last detail. It matters enormously for the longevity story.

One trial, no control arm, a real result

The approval rests on a single trial, QUILT-3.032. It is worth understanding exactly what it did and did not prove.2

Phase 2/3 · Single-arm · n=77 QUILT-3.032 — FDA label population, 2024

Design. Open-label, single-arm, multicenter trial in patients whose bladder cancer had stopped responding to BCG. The FDA evaluated efficacy in the 77-patient carcinoma in situ cohort. Anktiva was instilled into the bladder with BCG weekly for six weeks, with maintenance cycles thereafter.2,3

Results. A complete response rate of 62%. Among those responders, 58% stayed in complete response for at least a year and 40% for at least two years — meaningful durability for a population whose main alternative is removal of the bladder.1,2

Limitation: No randomized control group, so the benefit over BCG alone can't be cleanly quantified. A monotherapy cohort testing Anktiva without BCG was stopped for futility — the drug needs its partner. Funded by the manufacturer, ImmunityBio.6

This is a real result for real patients, and I won't pretend otherwise. For someone facing cystectomy — surgical removal of the bladder — a 62% complete response with multi-year durability is genuinely valuable. The criticism here is narrow and technical: single-arm trials make it hard to separate the drug's effect from the natural course of disease or from the BCG it's paired with, and some researchers have argued the efficacy bar for these uncontrolled bladder-cancer trials is set too low.16 Those are fair caveats about an approved oncology drug. They are not the problem with the longevity claim. The problem with the longevity claim is that there is no trial at all.

From immunosenescence theory to a sales pitch

So where does "longevity drug of the decade" come from? It comes from a chain of reasoning that sounds rigorous until you look at each link. Link one: as we age, our immune systems decline — a process called immunosenescence — and natural killer cells in particular lose their punch, becoming more numerous but less effective.10 Link two: this decline is associated with cancer, infection, and chronic inflammation, the so-called "inflammaging." Link three: Anktiva expands and activates natural killer cells. Therefore, the pitch concludes, Anktiva must rejuvenate the aging immune system and extend healthspan.11

Links one and two are supported by a serious body of research.10,11 Link three is where the argument quietly substitutes mechanism for evidence. "This drug acts on cells that decline with age" is not the same statement as "this drug reverses aging." The first is biochemistry. The second is a clinical claim that requires a clinical trial — measuring whether treated humans actually age more slowly, get sick less, or live longer. That trial does not exist.

"Acts on cells that decline with age" is not the same sentence as "reverses aging." One is biochemistry. The other needs a trial.

Dr. Maren Cole

What does exist is adjacent positioning. ImmunityBio has spoken of a "cancer BioShield" and of building durable immune memory, and in early 2025 secured a regenerative-medicine designation aimed at reversing lymphopenia — low lymphocyte counts — in patients depleted by chemotherapy and radiation.5 That is a plausible supportive-care use in sick patients. It is still not an aging study in healthy people, and it should not be laundered into one.

What happens when you actually test the theory

Here is the most important number in this entire issue: zero. That is the count of human longevity or anti-aging clinical trials of Anktiva. The only data in a healthy human population is a Phase 1 pharmacokinetic study — a safety-and-dosing study, not an outcomes study.9

Phase 1 · Healthy volunteers Romee et al. — pharmacokinetics of N-803, 2022

What it tested. The behavior of the drug in healthy adults: how long it lasts, how it's tolerated, and whether it expands the target immune cells. It confirmed the roughly twenty-hour half-life and expansion of natural killer and CD8 T cells, and it was well tolerated.9

Limitation: This is a pharmacokinetic and safety study. It measured cell counts, not aging, healthspan, disease incidence, or survival. More killer cells in a blood draw is a biomarker, not a benefit.

And when researchers have actually tested the underlying theory — does boosting IL-15 rejuvenate an aged immune system? — the answer has been humbling.

Preclinical · Aged mice Nair et al. — Aging Cell, 2015

What it found. Treating aged mice with IL-15 and its receptor massively expanded natural killer cell numbers — exactly what the longevity pitch promises. But the new cells stayed functionally immature and failed to restore antiviral protection. The aging defect traced back to the bone-marrow environment, not to a shortage of IL-15.9

Limitation: Mouse data, and not a test of Anktiva specifically. But it directly challenges the central premise: more killer cells did not equal a younger, more capable immune system.

There is a second wrinkle the pitch ignores. IL-15 is a pro-inflammatory cytokine. Chronically elevated IL-15 is associated with inflammaging — the low-grade, persistent inflammation that drives much age-related disease — and human IL-15 levels with age are genuinely complicated, with some very long-lived people showing higher, not lower, levels.10 Deliberately and chronically raising a pro-inflammatory signal to fight aging is, at minimum, a hypothesis that could cut the wrong way. It is not a settled good.

Anktiva by the Numbers
62%
Complete response in the pivotal bladder-cancer trial (n=77) — not an aging endpoint
$35,800
Per dose wholesale cost; a full course runs roughly $750K to over $1M
0
Human longevity trials of Anktiva; the only healthy-person data is a Phase 1 safety study

The drug's real-world evidence lives entirely in oncology. The aging column is empty.1,9,15

A controlling owner, a stack of lawsuits, and a warning from the FDA

When a medical claim outruns its evidence, follow the incentives. Patrick Soon-Shiong is the founder, executive chairman, and chief scientific and medical officer of ImmunityBio, and he controls roughly two-thirds of the company through affiliated entities.14 He also owns a major newspaper, which complicates any independent coverage his outlets might provide. None of that makes the science wrong. It does mean the loudest voice promoting Anktiva as a longevity drug is also its largest financial beneficiary.

The litigation is harder to wave away. A December 2024 investor lawsuit alleges Soon-Shiong exploited a stock decline through financing maneuvers that benefited his own entities while diluting ordinary shareholders, and separate securities-fraud suits allege the company overstated Anktiva's efficacy — claims that accompanied sharp share-price drops on regulatory news.14

And then there is the regulator. In early 2026, the FDA's Office of Prescription Drug Promotion issued a warning letter citing a direct-to-consumer television ad and a podcast appearance as false or misleading — for suggesting unapproved uses across "all cancers," framing the drug as a one-shot "cancer vaccine," and minimizing its risks. The FDA stated plainly it was not aware of data supporting claims that Anktiva can cure cancer.12,13 When the agency that approved your drug for bladder cancer has to publicly correct your claims about what else it does, that is the clearest possible signal that the marketing has detached from the evidence.

Wrong route entirely

Anktiva is approved as a bladder instillation. A longevity use would require systemic dosing, for which the favorable bladder-cancer safety profile simply does not transfer.3

Biomarker, not benefit

Expanding killer-cell counts is a lab finding. No study shows it translates into slower aging, fewer illnesses, or longer life in healthy people.9

Inflammation risk

IL-15 is pro-inflammatory. Chronically raising it is linked to inflammaging, the opposite of what a longevity therapy should do.10

Cost and conflicts

A six-figure-plus course, a controlling owner promoting the claims, active securities litigation, and an FDA warning letter.12,14,15

Two drugs, one name

Dr. Cole's Verdict

There are effectively two Anktivas in this conversation. The first is a legitimate, FDA-approved bladder-cancer immunotherapy with a real 62% complete-response rate and genuine value for patients trying to keep their bladders. I have no quarrel with that drug. If that were the whole story, this issue would carry a very different rating.

The second Anktiva — the "most important longevity drug of the decade" — exists only in promotional language. It has no human aging trial, no healthspan or lifespan outcome data, and no systemic-administration safety record for use in healthy people. The mouse data that tested its core premise found that more killer cells did not equal a rejuvenated immune system. Its loudest promoter controls the company and has just been warned by the FDA for overstating the drug's reach. That is not an evidence problem you can fix by waiting for more data. It is a claim that was never built on data to begin with.

I am rating the longevity claim Marketing Hype. The approved oncology use stands on its own and is not what's being judged here.

The Bottom Line
Marketing Hype

Anktiva is a real bladder-cancer drug wearing a longevity costume. Zero human aging trials, one FDA warning letter, and a promoter who owns the company. Judge the approved use on its merits; ignore the anti-aging pitch.

  1. U.S. Food and Drug Administration. FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. FDA.gov. April 22, 2024. (Approval; n=77; 62% complete response.)
  2. U.S. FDA. Drug Trials Snapshots: ANKTIVA. FDA.gov. 2024. (QUILT-3.032 single-arm design and efficacy population.)
  3. U.S. FDA. ANKTIVA prescribing information (label PDF). accessdata.fda.gov. 2024. (Intravesical administration, dosing, adverse reactions.)
  4. Chamie K. et al. FDA approval summary: nogapendekin alfa inbakicept-pmln with BCG for BCG-unresponsive CIS. PMC. 2025.
  5. ImmunityBio. Press materials on RMAT designation for lymphopenia reversal and clinical program expansion. businesswire.com. 2024–2025. (Company source; note bias.)
  6. Urology Times. QUILT-3.032 trial: Anktiva achieves high response rate in BCG-unresponsive NMIBC. urologytimes.com. 2024. (Cohorts; monotherapy futility; durability.)
  7. Review. Interleukin-15 biology: NK and CD8 T-cell expansion without regulatory T-cell expansion. PMC. 2025.
  8. Review. IL-15: from discovery to FDA approval — IL-15Rα-Fc fusion design and extended half-life. PMC. 2025.
  9. Romee R. et al. Phase 1 pharmacokinetics of N-803 in healthy volunteers. PubMed. 2022. And: Nair S. et al. IL-15 expands but does not restore NK function in aged mice. Aging Cell. 2015.
  10. Review. Targeting immunosenescence and inflammaging; IL-15 and NK-cell aging biology. Experimental & Molecular Medicine / Nature. 2025.
  11. Review. Adoptive NK-cell therapy as a potential approach in longevity therapeutics (proof-of-concept; not Anktiva). PMC. 2024.
  12. CBS News. FDA warns manufacturer that billionaire's claims about cancer drug Anktiva are misleading. cbsnews.com. March 2026.
  13. FiercePharma. ImmunityBio hit with FDA warning letter over Anktiva promotions in TV ad, podcast episode. fiercepharma.com. 2026.
  14. Bloomberg Law / BNN Bloomberg. Biotech billionaire Soon-Shiong sued over ImmunityBio stock move. bnnbloomberg.ca. December 3, 2024.
  15. MedFinder / The Pricer / Drugs.com. Anktiva pricing: ~$35,800 per dose; ~$750K–$1M+ per course. 2024–2025.
  16. Analysis. Required efficacy benchmarks for novel therapies in BCG-unresponsive NMIBC. PMC. 2020.