UCLA
Karim Chamie, MD
Lead investigator of the pivotal bladder-cancer trial and first author of the NEJM Evidence report. On what the approval means and why IL-15 matters (Oncology Central interview; UCLA Health).
How the count comes back
A medicine that treats the immune system, not just the tumor.
Chemotherapy and radiation kill dividing cells, and the lymphocytes that hunt cancer are collateral damage. Anktiva is an IL-15 signal that tells the body to make more of its own natural killer cells and T cells, and to keep them alive longer. It is the reason Beth's count went from 525 to 1,400 after one injection.
Anktiva + BCG: FDA expands approval for BCG-unresponsive bladder cancer
FDA decision: October 14, 2026. Website update prepared: October 16, 2026.
The FDA has expanded the approved use of Anktiva (nogapendekin alfa inbakicept-pmln), in combination with Bacillus Calmette-Guérin (BCG), to include adults with BCG-unresponsive, high-grade papillary-only non-muscle-invasive bladder cancer. The FDA describes Anktiva as the first approved treatment specifically for this patient population. (FDA announcement)
What has changed?
Previously, the approved indication required carcinoma in situ (CIS), with or without papillary tumors; the expanded indication also includes high-grade papillary-only disease without CIS. (FDA approval details)
In plain language, the additional group has bladder cancer that has not grown into the bladder’s muscle layer and has not responded adequately to BCG treatment. (FDA announcement)
Why did the FDA expand the indication?
The FDA considered the previously demonstrated effectiveness of Anktiva plus BCG in patients with CIS alongside clinical and laboratory evidence showing important similarities between CIS and high-grade papillary tumors. These similarities supported applying the earlier efficacy evidence to high-grade papillary-only disease. (FDA approval details)
What this does not mean
This decision does not approve Anktiva for all cancers, for cancer prevention, or simply to raise a low absolute lymphocyte count; the approved use described here is Anktiva with BCG, administered directly into the bladder. (FDA approval details)
Do not interpret a patient story about another cancer or treatment route as evidence that this approval covers that use.
Important safety information
The FDA warns that delaying cystectomy, surgery to remove the bladder, can allow bladder cancer to become metastatic, which can be fatal. (FDA approval details)
Common adverse reactions and laboratory abnormalities include urinary pain, blood in the urine, urinary frequency and urgency, urinary tract infections, muscle or joint pain, chills, fever, and increased creatinine and potassium. (FDA approval details)
Ask your urologist or oncology team whether your diagnosis and previous treatments meet the approved criteria, how this option compares with surgery or other treatments, and how your response would be monitored.
This summary is educational and is not a substitute for the full prescribing information or individualized medical advice.
The news version
Watch it attack the cancer and rebuild the defense.
NewsNation's Killing Cancer series explains in five minutes what the rest of this site documents in footnotes: how IL-15 binds to natural killer cells, multiplies them, makes them stronger and longer-lived, and sends them after abnormal cells, and why chemotherapy and radiation leave that army depleted (NewsNation, Nov 26, 2025).
- Signal. Anktiva (nogapendekin alfa inbakicept) is an interleukin-15 receptor superagonist approved for administration into the bladder with BCG in a specific bladder-cancer setting; injection routes for other uses are investigational. IL-15 is the body's own instruction to natural killer cells and CD8 T cells to grow (FDA).
- Multiply. In the FDA's own review, binding the IL-15 receptor "results in proliferation and activation of NK, CD8+, and memory T cells without proliferation of immuno-suppressive regulatory T cells" (FDA multidisciplinary review). The phase 1 trial showed NK-cell expansion and early CD8 T-cell activation; circulating CD8 counts increased only modestly, and no objective tumor responses occurred (Margolin et al., 2018).
- Remember. Memory T cells persist. In the approved bladder-cancer use, 62% of patients had a complete response and 58% of those responses lasted a year or more; in the full 100-patient cohort, 84% of responders still had their bladder at 36 months (FDA; Chang, AUA 2025).
- In one chart. Beth: 525 in January 2026, 1,400 after her first injection in February, 1,131 and holding in July. Her chapter →
In his own words
Dr. Patrick Soon-Shiong on the cells that kill cancer.
The surgeon and scientist behind Anktiva has explained the idea to oncologists and to general audiences. Start with whichever room you sit in.
"We have, within our body, the power within us to stimulate the very cells that kill cancer with a simple subcutaneous injection."Dr. Patrick Soon-Shiong, Oncology Brothers, Feb 2026
Oncology Brothers · Journal Club"Current & Future Role of Anktiva (N-803)." Two practicing oncologists interview Dr. Soon-Shiong on IL-15, NK cells, CD8 memory T cells and lymphopenia. February 9, 2026.For clinicians · YouTube
The Tucker Carlson ShowThe interview Beth saw. Why cancer is rising in the young, how the immune system is meant to clear it, and the "BioShield" idea of activating NK and T cells. March 26, 2025 · 1 h 49 min.General audience · YouTube
Spencer Lodge Podcast"Are we finally winning against cancer?" Dr. Soon-Shiong on IL-15 as "the number one ranked molecule," NK cells, and the pandemic of cancer. March 2, 2026 · 55 min.General audience · YouTube
GU Oncology Now · How it worksSeven minutes on mechanism: NK cells recognize tumor cells that hide from T cells, interferon-gamma restores the tumor's visibility, and T cells finish the job. May 6, 2024.For clinicians · YouTube
The Sean Spicer Show"We are attempting to prevent cancer." On the fully accrued NCI trial of IL-15 plus a tumor-targeting adenovirus in people with Lynch syndrome. June 19, 2026 · 49 min.Policy audience · YouTube
OncoDaily · "Expanded access is not enough""The first IL-15 protein biologic in the history of medicine with an approved FDA label that states it expands your NK and T cells." On why lymphopenia needs a label, not a program. November 2025.Read · OncoDaily
Other physicians
The doctors who have used it.
Vanderbilt
Sam S. Chang, MD, MBA
Presented the long-term results at AUA 2025: 71% complete response, median duration 45 months, and most responders keeping their bladder at three years (UroToday video; Urology Times).
Central New York
Justin's urologist
A surgeon who performs cystectomies for a living, on his first Anktiva patient: "How Anktiva works is to make the tumors go from cold to hot, and then the immune system is a powerful tool to then scavenge those cancer cells and keep them at bay." Watch in Killing Cancer →
Lisa's oncologist
Dr. Reese
On a myeloma remission that has outlasted every expectation: "I think what will probably revolutionize the care is immune treatment. The field is looking at immune treatments that try to rev up someone's own NK cells." Watch in Killing Cancer →
Cedars-Sinai
Andrew's oncologist
Glioblastoma, clean scans after standard care plus Anktiva. Andrew, quoting his oncologist: "He's never seen that at that sort of level," and, "I'm very excited that you're willing to pioneer these different treatments." Watch in Killing Cancer →
Regulators and registries
FDA expanded access for lymphopenia
In June 2025 the FDA authorized an Expanded Access Program for Anktiva to reverse and maintain the lymphocyte count in adults with solid tumors after chemotherapy, immunotherapy or radiation (NCT06956547; Urology Times).
The patients
What it did for them.
JustinBladder cancer · treated under the FDA approval
It gave me almost like a supercharged feeling. I was golfing the next day.ValerieStage 4 lung cancer, 24 tumors, "six to eight weeks"
75% to 80% improved in just two months. He called me his miracle patient.AndrewGlioblastoma · Anktiva after chemo and radiation
I had an MRI scan January 13th, came back clean. My last scan came back clean.AlanRecurrent prostate cancer · Anktiva before radiation
Within 10 days of that shot, my PSA went to undetectable levels.BethStage 3 colon cancer · lymphocytes stuck at 525 for two years
After the first injection, my lymphocytes went from 525 to 1,400. One shot.Jim and BillyNewsNation · "Saved my life"
Two more trial patients describe their results, and the access problem that remains.
More patient accounts, including Irv and Wayne, are published by the manufacturer at anktiva.com/patient-stories. Individual results vary; these are the patients' own words, not a promise.
Ask about it
If your count is low, there is now something to ask for.
Management of a low lymphocyte count depends on its cause and the patient's treatment. Today there is an FDA-approved medicine for one cancer, an FDA-authorized expanded-access program for lymphopenia in solid tumors, and trials enrolling in glioblastoma, pancreatic, lung and prostate cancer. Bring the number and the question.
- Get your absolute lymphocyte count from your last CBC with differential, and your pre-treatment baseline if you have one. Check your number →
- Ask your oncologist: "My count is below 1,000. Am I eligible for the Anktiva expanded-access program for lymphopenia, or a trial that restores lymphocytes?" (NCT06956547)
- Hand them the policy and clinician page, which has the literature and the regulatory record with sources.
Honest label. Anktiva is FDA-approved, since April 22, 2024, with BCG for BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ (FDA). Its use to restore lymphocytes is investigational: available through expanded access and clinical trials, with RMAT designation, and not yet an approved indication. Much of the lymphopenia data is company-reported and single-arm. The FDA issued the manufacturer a warning letter about promotional claims on March 13, 2026 (FDA). This site links the label, the registries and the interviews so you can weigh them yourself. Educational, not medical advice.
October 14, 2026: The FDA expanded Anktiva plus BCG to include adults with BCG-unresponsive, high-grade papillary-only non-muscle-invasive bladder cancer. This broadens the previous indication, which required carcinoma in situ (CIS), with or without papillary tumors. (FDA announcement) Read the full update
Primary documents
Read the sources yourself.
Everything this page says about Anktiva traces to one of the documents below. Regulatory records first, then peer-reviewed papers, then the company's own statements, which are marked and should be weighed as such.
Regulatory record FDA · EMA · registries
- FDA approval notice, April 22, 2024 FDANogapendekin alfa inbakicept-pmln with BCG for BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ. Complete response 62% (95% CI 51–73); 58% of responses lasted ≥12 months. Intravesical use only.fda.gov · approval notice →
- FDA multidisciplinary review, BLA 761336 FDAThe agency's own clinical, statistical and pharmacology review behind the approval, including the efficacy and safety tables.accessdata.fda.gov · review (PDF) →
- Prescribing information (label) FDAIndication, dosing, warnings, and the most common adverse reactions (≥15%): increased creatinine, dysuria, hematuria, urinary frequency and urgency, UTI, increased potassium, musculoskeletal pain, chills, fever. Current version on DailyMed; the annotated approved label is also hosted by the manufacturer.dailymed.nlm.nih.gov · label → approved label (PDF) →
- FDA warning letter to ImmunityBio, March 13, 2026 FDAObjects to promotional claims about the drug. Included so readers can weigh the company's statements with the regulator's response in view.fda.gov · warning letter →
- Expanded-access protocol for lymphopenia, NCT06956547 RegistryReversal and maintenance of the absolute lymphocyte count in patients with relapsed or refractory solid tumors and ALC below 1,000/µL. Expanded access is not approval and does not establish efficacy.clinicaltrials.gov · NCT06956547 → Reagan-Udall Navigator listing →
- FDA: how expanded access works FDAPhysician and patient contacts for single-patient and intermediate-size expanded access requests.fda.gov · expanded access contacts →
- European Medicines Agency public assessment report EMAThe European regulator's independent assessment of the same bladder-cancer data.ema.europa.eu · EPAR (PDF) →
Peer-reviewed papers mechanism · phase 1 · pivotal trial
- Margolin K, et al. Phase I trial of ALT-803 in patients with advanced solid tumors. Clinical Cancer Research, 2018.First-in-human study of the molecule now sold as Anktiva. NK cells expanded and CD8 T cells showed early activation, with modest increases in circulating CD8 counts. One of seven evaluable patients had an increase in regulatory T cells. No objective tumor responses occurred. Most common effects: injection-site reactions and flu-like symptoms.PMC6239933 →
- Chamie K, et al. IL-15 superagonist NAI in BCG-unresponsive non-muscle-invasive bladder cancer (QUILT-3.032). NEJM Evidence, 2023.Peer-reviewed report of the pivotal cohort: complete response 71%, median duration 26.6 months.PubMed 38320011 →
- Knudson KM, et al. Mechanisms involved in IL-15 superagonist enhancement of anti-PD-L1 therapy. Journal for ImmunoTherapy of Cancer, 2019.How N-803 drives NK and CD8 T-cell expansion and why it may pair with checkpoint inhibitors.PMC6429734 →
- Waldmann TA, Dubois S, Miljkovic MD, Conlon KC. IL-15 in the combination immunotherapy of cancer. Frontiers in Immunology, 2020.Review of interleukin-15 biology from the NIH group that first characterized the cytokine.PubMed 32508818 →
- Waldmann TA. The biology of interleukin-2 and interleukin-15: implications for cancer therapy and vaccine design. Nature Reviews Immunology, 2006.Why IL-15, unlike IL-2, supports NK and memory CD8 T cells without expanding regulatory T cells.nature.com · nri1901 →
- Phase I pharmacokinetics of subcutaneous N-803. The Journal of Immunology, 2022.Dose, half-life and lymphocyte response after subcutaneous administration, the route used in the lymphopenia program.academic.oup.com →
For the studies linking a low lymphocyte count to survival, independent of any drug, see the evidence page.
Company-reported press releases · not peer-reviewed
- ImmunityBio: FDA expanded-access authorization for lymphopenia in solid tumors, June 2025 CompanyAnnouncement of the program Beth entered. Company language; the FDA authorization itself is documented by the registry entries above.immunitybio.com →
- Chan Soon-Shiong Institute for Medicine: lymphopenia program page CompanyThe clinic where the expanded-access protocol is administered, and where Beth received her ten injections.cssifm.org →
- ImmunityBio: QUILT-88 pancreatic cancer responder analysis, ASCO 2025 CompanyReports an overall-survival HR of 0.46 for patients whose lymphopenia reversed. A responder analysis, not a randomized comparison; subject to immortal-time bias.immunitybio.com →
Missing a document that should be here? Send it to us. Reviewed against these sources on September 6, 2026.
Last reviewed:
Reviewed by: LymphocyteCount.org editors, against the primary sources linked on this page
How we review · Report an error