# Nogapendekin alfa inbakicept

Nogapendekin alfa inbakicept (Anktiva, Immunitybio Ireland Limited) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Urothelial carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + Bacillus Calmette-Guérin (BCG) | Early | Non-muscle-invasive with carcinoma in situ only; BCG-unresponsive; with or without papillary tumours Ambiguous in the label (stage): check the SmPC. |

## Products

### Anktiva

- Company: Immunitybio Ireland Limited
- Target: IL-15 receptor agonist
- ATC: L03AC03
- EU approval: 16 Feb 2026
- Label revised: 12 Jun 2026
- Status: conditional approval
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/anktiva-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/anktiva-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/anktiva

Mechanism (SmPC section 5.1): Binds the IL-15 receptor (shared IL-2/IL-15 βc/γc) to drive proliferation and activation of NK, CD4+, CD8+ and memory T cells without expanding immunosuppressive Treg cells.

## Label wording

- **Nogapendekin alfa inbakicept** (Anktiva), Urothelial carcinoma, early: “ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/anktiva-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/nogapendekin-alfa-inbakicept