Nogapendekin alfa inbakicept
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.
QUILT 3.032: CR 71% in BCG-unresponsive CIS; long bladder preservation in responders. FDA approval 22 April 2024 after a 2023 complete response letter. ImmunityBio; expanding into BCG-naive disease and papillary-only cohorts.
1.Co-instilled with BCG
- Route
- Intravesical with BCG
- Schedule
- 400 µg with BCG weekly ×6, re-induction if needed, then maintenance at months 4, 7, 10, 13, 19 (and up to 37)
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: nogapendekin alfa inbakicept. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | BCG-unresponsive NMIBC with CIS ± papillary tumours, with BCG |
| 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.
Trials
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Landmark trials in OnCo
Latest papers
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