On October 14, 2026, the US Food and Drug Administration (FDA) approved an expanded indication for nogapendekin alfa inbakicept-pmln (Anktiva) in combination with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC).
The approval expands the previous indication, which was limited to patients with carcinoma in situ (CIS), with or without papillary tumors, to include patients with high-grade papillary-only tumors. Anktiva is licensed to Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.
What Is Anktiva?
Anktiva (nogapendekin alfa inbakicept-pmln) is an interleukin-15 (IL-15) receptor agonist immunotherapy. Anktiva works by stimulating the body’s immune response, including the activation of natural killer (NK) cells, which are part of the immune system and can recognize and kill cancer cells. Unlike chemotherapy, Anktiva is designed to enhance the body’s immune response against cancer. The treatment is administered directly into the bladder through a catheter (intravesically) in combination with Bacillus Calmette-Guérin (BCG). It is not administered intravenously or subcutaneously.
Anktiva was previously approved in combination with BCG for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The October 14, 2026, FDA decision expanded this indication to include patients with high-grade papillary-only tumors.
Clinical Evidence from QUILT-3.032
The previously demonstrated efficacy of nogapendekin alfa inbakicept-pmln with BCG was established in Cohort A of QUILT-3.032 (NCT03022825), a single-arm, multicenter clinical trial. The cohort included 77 patients with BCG-unresponsive, high-risk NMIBC with CIS, with or without Ta/T1 papillary disease, following transurethral resection.
Patients received intravesical nogapendekin alfa inbakicept-pmln with BCG as induction therapy, followed by maintenance treatment for up to 37 months. The main efficacy endpoint was complete response (CR), assessed through cystoscopy, urine cytology, and biopsy. Duration of response (DoR) was an additional efficacy endpoint.
Key efficacy findings included:
- The complete response rate was 62% (95% CI: 51–73).
- Among patients who achieved CR, 58% maintained their response for at least 12 months.
- Among patients who achieved CR, 40% maintained their response for at least 24 months.
These results were obtained in patients with CIS-containing disease and formed the basis of the previously established efficacy of the combination.
Basis for the Expanded Indication
The FDA expanded the indication to include patients with BCG-unresponsive high-grade papillary-only NMIBC following a review of available scientific information.
Although CIS and high-grade papillary tumors have different architectural growth patterns, the FDA noted that both are aggressive forms of urothelial carcinoma. They frequently coexist, may be difficult to distinguish pathologically, and are associated with a high risk of recurrence and progression in the BCG-unresponsive setting. Based on their overlapping clinical and nonclinical characteristics, the FDA concluded that the previously demonstrated efficacy of nogapendekin alfa inbakicept-pmln with BCG in CIS-containing NMIBC could be extrapolated to patients with high-grade papillary disease.
The expanded indication was therefore supported by extrapolation of existing efficacy evidence, rather than a separately reported efficacy analysis in the papillary-only population. The FDA is also working toward finalizing its guidance for industry on developing treatments for BCG-unresponsive NMIBC to address this approach.
Safety Profile
The most common adverse reactions and laboratory abnormalities, reported in at least 15% of patients, included increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. The prescribing information also includes an important warning that delaying cystectomy may lead to the development of metastatic bladder cancer, which can be lethal.
Recommended Dosage and Administration
The recommended dose of nogapendekin alfa inbakicept-pmln is 400 mcg administered intravesically with BCG once weekly for six weeks during induction therapy. A second induction course may be administered to patients with residual CIS and/or high-grade Ta tumors at month 3. Maintenance treatment consists of 400 mcg administered intravesically with BCG once weekly for three weeks at months 4, 7, 10, 13, and 19, for a total of 15 maintenance doses.
For patients without evidence of high-grade disease at month 25 and later, additional maintenance instillations with BCG may be administered once weekly for three weeks at months 25, 31, and 37, for up to nine additional instillations. Treatment should be discontinued in cases of persistent disease after the second induction course, disease recurrence or progression, or unacceptable toxicity. The maximum treatment duration is 37 months.
Clinical Implications
The FDA’s decision expands the approved use of nogapendekin alfa inbakicept-pmln with BCG beyond CIS-containing NMIBC to include patients with BCG-unresponsive high-grade papillary-only tumors.
Importantly, the expansion relies on the FDA’s assessment that efficacy demonstrated in patients with CIS-containing disease can be extrapolated to high-grade papillary disease. The previously reported response rates from QUILT-3.032 should not be interpreted as direct efficacy results in patients with papillary-only tumors.
The expanded indication broadens the population eligible for treatment with Anktiva plus BCG, while the warning regarding delayed cystectomy remains an important consideration in clinical management.
The full announcement is available on official FDA website.
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