# Brexucabtagene autoleucel

Brexucabtagene autoleucel (Tecartus, Kite Pharma EU B.V.) has 2 EU-approved indications in 2 tumour types.

## Approved indications

### Acute lymphoblastic leukaemia

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

### Mantle cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+ | After two or more lines of systemic therapy including a BTK inhibitor |

## Products

### Tecartus

- Company: Kite Pharma EU B.V.
- Target: CD19-directed CAR T-cell therapy
- Class: Other antineoplastic agents
- ATC: L01X
- EU approval: 14 Dec 2020
- Label revised: 19 May 2026
- Status: conditional approval, orphan medicine, PRIME, advanced therapy
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tecartus-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tecartus

Mechanism (SmPC section 5.1): Binds to CD19-expressing cancer and normal B cells, activating intracellular signaling that induces T-cell proliferation, effector functions, and killing of target cells.

## Label wording

- **Brexucabtagene autoleucel** (Tecartus), Mantle cell lymphoma, 3rd line+: “Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf)
- **Brexucabtagene autoleucel** (Tecartus), Acute lymphoblastic leukaemia, 2nd line: “Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecartus-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/brexucabtagene-autoleucel