# Tagraxofusp

Tagraxofusp (Elzonris, Stemline Therapeutics B.V.) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Blastic plasmacytoid dendritic cell neoplasm

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 1st line | - |

## Products

### Elzonris

- Company: Stemline Therapeutics B.V.
- Target: CD123-directed cytotoxin
- Class: Other antineoplastic agents
- ATC: L01XX67
- EU approval: 7 Jan 2021
- Label revised: 27 Oct 2025
- Status: exceptional circumstances, orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/elzonris-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/elzonris-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/elzonris

Mechanism (SmPC section 5.1): It targets CD123-expressing cells and irreversibly inhibits protein synthesis by inactivating elongation factor 2, causing apoptosis.

## Label wording

- **Tagraxofusp** (Elzonris), Blastic plasmacytoid dendritic cell neoplasm, 1st line: “ELZONRIS is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/elzonris-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/tagraxofusp