# Obecabtagene autoleucel

Obecabtagene autoleucel (Aucatzyl, Autolus GmbH) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Acute lymphoblastic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | B-cell precursor ALL only; Relapsed or refractory disease; 26 years of age and above |

## Products

### Aucatzyl

- Company: Autolus GmbH
- Target: CD19-directed CAR T-cell therapy
- Class: Antineoplastic cell and gene therapy
- ATC: L01XL
- EU approval: 17 Jul 2025
- Label revised: 19 Aug 2025
- Status: conditional approval, PRIME, advanced therapy
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/aucatzyl-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/aucatzyl-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/aucatzyl

Mechanism (SmPC section 5.1): Autologous CAR T cells bind CD19 on target cells, leading to CAR T-cell activation, proliferation, and anti-tumour killing of CD19-expressing cells.

## Label wording

- **Obecabtagene autoleucel** (Aucatzyl), Acute lymphoblastic leukaemia, 2nd line: “Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/aucatzyl-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/obecabtagene-autoleucel