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Nogapendekin alfa inbakicept is an engineered version of the immune-boosting protein IL-15, given with BCG into the bladder, approved in 2024 for early bladder cancer that BCG alone no longer controls.
Nogapendekin alfa inbakicept is an IL-15 superagonist, an IL-15/IL-15R alpha-Fc fusion that expands natural killer cells and memory CD8 T cells without preferentially stimulating regulatory T cells. It is instilled into the bladder together with BCG, weekly for 6 weeks and then as maintenance for up to 37 months. In QUILT 3.032 the combination produced a complete response in 71% of patients with BCG-unresponsive carcinoma in situ, with long bladder preservation in responders. The FDA approved it on 22 April 2024 after a 2023 complete response letter over manufacturing; side effects are mostly local, with grade 3 or higher treatment-related events in only 3%. ImmunityBio is expanding into BCG-naive disease and papillary-only cohorts. The idea is to make BCG work again by giving the immune cells it recruits a stronger signal.
IL-15/IL-15Rα-Fc fusion that expands NK and memory CD8 T cells without preferentially stimulating regulatory T cells.
1.Co-instilled with BCG
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Intravesical, given with BCG in the urology clinic.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. Plans require BCG-unresponsive NMIBC with carcinoma in situ.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA1163. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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| Region | Year | Indication |
|---|---|---|
| US | 2024 | BCG-unresponsive NMIBC with CIS ± papillary tumours, with BCG |
| EU | 2026 | BCG-unresponsive NMIBC with CIS, with BCG; 16 Feb 2026 (conditional) · Conditional marketing authorisation |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Dysuria | 22% | - |
| Haematuria | 17% | - |
| Urinary frequency | 15% | - |
| Grade 3+ treatment-related | - | 3% |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Nogapendekin alfa inbakicept" OR ABSTRACT:"Nogapendekin alfa inbakicept" OR TITLE:"Anktiva" OR ABSTRACT:"Anktiva" OR TITLE:"N-803" OR ABSTRACT:"N-803" OR TITLE:"ALT-803" OR ABSTRACT:"ALT-803" OR TITLE:"NAI" OR ABSTRACT:"NAI" OR TITLE:"nogapendekin-alfa-inbakicept" OR ABSTRACT:"nogapendekin-alfa-inbakicept") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Nogapendekin alfa inbakicept, not a curated reading list.
Shares Valrubicin, BCG-unresponsive, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Non-muscle-invasive bladder cancer.
Shares BCG-unresponsive, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Non-muscle-invasive bladder cancer, Bladder & urothelial cancer.
Shares QUILT 3.032, BCG-unresponsive, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Bladder & urothelial cancer.
Shares BCG-unresponsive, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Non-muscle-invasive bladder cancer, Bladder & urothelial cancer.
Shares BCG-unresponsive, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Bladder & urothelial cancer.
Shares Valrubicin, Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Bladder & urothelial cancer.
Shares Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy), Non-muscle-invasive bladder cancer, Bladder & urothelial cancer.