Approved treatment — U.S. FDA (2026-10-14), BCG-unresponsive non-muscle invasive bladder cancer (CIS and papillary-only) EU, UK, Saudi Arabia, Macau — approved for patients with carcinoma in situ (CIS)
Options for BCG-unresponsive bladder cancer have widened. On October 14, 2026, the U.S. FDA expanded the use of Anktiva (nogapendekin alfa inbakicept), an intravesical immunotherapy that activates NK cells and T cells, given together with BCG — from patients with carcinoma in situ (CIS) to patients with high-grade papillary-only tumors. In the pivotal trial, 62% of patients with CIS reached a complete response (no cancer visible on testing), and 40% of responders kept that response for two years or longer.
What was newly approved: expansion to papillary-only BCG-unresponsive disease
Bladder cancer that stays in the bladder lining is called non-muscle invasive bladder cancer (NMIBC). When the risk of recurrence is high, the standard approach is endoscopic resection followed by BCG, a tuberculosis vaccine strain instilled into the bladder. If high-grade cancer persists or returns despite adequate BCG, the disease is classed as “BCG-unresponsive,” and the most established next step has been radical cystectomy — removal of the whole bladder. Patients who wished to keep their bladder had few choices.
When Anktiva was first approved in the U.S. in April 2024, it could be used only for BCG-unresponsive patients with CIS (a flat, high-grade cancer spreading along the lining). The new decision adds patients who have high-grade papillary tumors (Ta/T1, raised mushroom-like growths) without CIS. According to the company, about 85% of NMIBC presents as papillary disease, so many more patients can now consider a bladder-sparing option. The FDA concluded that efficacy shown in CIS could be extrapolated to papillary disease because both are aggressive urothelial cancers with similar clinical features in this setting.
How it works: an IL-15 agonist that activates NK cells
Anktiva is a fusion protein that strengthens the action of the immune messenger interleukin-15 (IL-15). Inside the bladder it binds IL-15 receptors on NK (natural killer) cells and CD4+ and CD8+ T cells, expanding and activating them. NK cells are innate immune cells that attack cancer cells without prior training, while T cells leave a memory that helps prevent recurrence. The company says this two-pronged action reinforces the immune response to BCG. Very little reaches the bloodstream (no systemic drug levels were detected in the trial), so its activity stays within the bladder. For an overview of NK-cell treatments see NK cell information, and for cell therapies see CAR-NK vs CAR-T differences.
Who it is for: adults with high-grade disease remaining after BCG
- Adults with BCG-unresponsive NMIBC whose high-grade cancer persisted or recurred after resection and adequate BCG
- Those with CIS, with or without papillary tumors — existing indication
- Those with high-grade papillary-only (Ta/T1) tumors without CIS — newly added
Muscle-invasive bladder cancer and cancer that has spread to other organs are not included. The choice is made with your doctor, depending on whether cystectomy is feasible for you and whether you prefer a bladder-sparing approach.
QUILT-3.032 results: complete responses and bladder preservation
The evidence comes from the multicenter single-arm trial QUILT-3.032 (NCT03022825). Analysing 77 patients in the CIS cohort, the FDA found a complete response rate of 62% (95% CI 51–73%); among complete responders, 58% maintained the response for 12 months or more and 40% for 24 months or more. In the data supporting European approval (100 patients), the complete response rate was 71% and the median duration of complete response was 26.6 months.
The final results summary on the European Association of Urology education site reports the two cohorts as follows.
| Item | CIS cohort | Papillary-only cohort |
|---|---|---|
| Patients | 83 | 77 |
| Main result | Complete response 71% | 12-month disease-free survival 57% |
| Longer-term result | Median duration of response 24.1 months | 24-month disease-free survival 48% |
| Avoided cystectomy | 91% | 95% |
Source: Chang S et al., final clinical results of the QUILT-3.032 CIS and papillary cohorts (UROONCO, European Association of Urology). The analysis time point and patient numbers differ from the FDA analysis (77 patients, 62% complete response).
Across all patients, 2-year bladder-cancer-specific survival was 99%, and in the CIS cohort 96% had not progressed to muscle-invasive disease at 2 years. In the European approval data, cystectomy-free survival among responders was 96% at 12 months, 90% at 24 months and 84% at 36 months. The key meaning of this treatment is that many patients continued care while keeping their bladder.
Treatment schedule and side effects: an outpatient bladder instillation
Anktiva 400 micrograms is mixed with BCG, instilled into the bladder through a urinary catheter, held for a period and then voided. Induction is once weekly for 6 weeks; if CIS or high-grade Ta disease remains at month 3, a second induction course may be given. Maintenance follows as 3 weekly doses at months 4, 7, 10, 13 and 19, and if there is no high-grade disease at month 25 or later, further maintenance at months 25, 31 and 37, for up to 37 months in total.
Common side effects were painful urination (22%), frequent urination (19%), blood in the urine (18%), fatigue (16%) and urgency (12%), mostly grade 1–2 bladder irritation similar to BCG alone. Among 180 patients in both cohorts, treatment-related grade 3 adverse events occurred in 3%, with no grade 4 or 5 events. Symptoms are managed with fluids, pain relief and, if needed, adjusted treatment timing. The FDA label warns that delaying cystectomy when the cancer does not respond may allow the disease to progress, so regular cystoscopy and urine cytology on schedule are important. It may harm an unborn baby during pregnancy.
Where it is available: U.S., Europe, UK, Middle East and Macau
- United States: approved in April 2024 for patients with CIS; expanded on October 14, 2026 to papillary-only disease (approved treatment).
- European Union: conditional marketing authorization in February 2026 — the 27 EU states plus Iceland, Liechtenstein and Norway, for patients with CIS.
- United Kingdom: MHRA approval in July 2025. Saudi Arabia: accelerated approval in January 2026.
- Asia: first Asian approval in Macau in March 2026. As of the check date there is no announced application in Japan, so in Japan patients first review insured treatments for BCG-unresponsive disease and possible clinical trials.
As of the check date, the papillary-only use is approved first in the U.S. If you are considering treatment abroad, review that country’s approved indication and cost, and whether you can stay or travel for a schedule lasting up to 37 months. How to read information published by Japanese medical institutions is explained in other Japan medical information.
What patients should check — questions for your doctor
- Does my situation meet the BCG-unresponsive definition (high-grade disease persisting or recurring after adequate BCG)?
- Do I have CIS, or only high-grade papillary tumors?
- What are the pros and cons of cystectomy versus bladder-sparing options (Anktiva, pembrolizumab, the gene therapy nadofaragene firadenovec and others)?
- How often will I have cystoscopy and urine tests during treatment, and what is the next step if it does not work?
- Is this treatment available in my country, or is there a clinical trial I can join?
Frequently asked questions
What is BCG-unresponsive bladder cancer?
It is non-muscle invasive bladder cancer in which high-grade cancer remains, or returns within a set period, despite adequate BCG treatment in the bladder. At this point cystectomy or a newer bladder-sparing treatment is considered.
Is Anktiva an NK cell therapy?
It is not a cell therapy made by growing a patient’s cells. It is an IL-15 agonist protein that activates the body’s own NK cells and T cells. It is mixed with BCG and instilled into the bladder, where its action stays.
How effective is Anktiva?
In the FDA analysis, 62% of 77 patients with CIS reached a complete response, and 40% of responders maintained it for two years or more. In papillary-only patients, 12-month disease-free survival was 57% and 95% avoided cystectomy.
Are Anktiva side effects severe?
Bladder irritation such as painful urination, frequency and blood in the urine was common, mostly grade 1–2 and similar to BCG alone. Treatment-related grade 3 adverse events occurred in 3%.
Related: CAR-NK vs CAR-T differences · NK cell therapy information · All NK cell articles
Sources
- U.S. FDA — FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer (2026-10-14)
fda.gov
Checked: 2026-10-20 - ImmunityBio — FDA Expands ANKTIVA Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease (2026-10-14)
ir.immunitybio.com
Checked: 2026-10-20 - Chang S, Chamie K, Hidalgo M, et al. Final clinical results of pivotal trial of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive NMIBC: CIS and papillary cohorts (UROONCO, European Association of Urology)
bladder.uroonco.uroweb.org
Checked: 2026-10-20 - ImmunityBio (Business Wire) — Authorization from the European Commission for ANKTIVA with BCG for NMIBC carcinoma in situ (2026-02-18)
businesswire.com
Checked: 2026-10-20 - Pharmaceutical Technology — ImmunityBio secures Macau approval for Anktiva combination (2026-03-23)
pharmaceutical-technology.com
Checked: 2026-10-20
Written by the FTH editorial team. Sources checked 2026-10-20 · Medical review: not applicable
This article is general information based on public sources and does not replace diagnosis or treatment. Please discuss treatment decisions with your medical team.
