# Tisagenlecleucel

Tisagenlecleucel (Kymriah, Novartis Europharm Limited) has 3 EU-approved indications in 3 tumour types.

## Approved indications

### Acute lymphoblastic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | B-cell precursor ALL only; Refractory, in relapse post-transplant or in second or later relapse; Up to and including 25 years of age |

### Large B-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+ | DLBCL only; After two or more lines of systemic therapy |

### Follicular lymphoma

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

## Products

### Kymriah

- Company: Novartis Europharm Limited
- Target: CD19-directed CAR T-cell therapy
- Class: Antineoplastic cell and gene therapy
- ATC: L01XL04
- EU approval: 23 Aug 2018
- Label revised: 1 Sep 2026
- Status: orphan medicine, PRIME, advanced therapy
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/kymriah-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/kymriah-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/kymriah

Mechanism (SmPC section 5.1): Autologous CAR T cells recognise CD19 on target cells, activating T-cell signalling to expand, persist, and eliminate CD19-expressing cells.

## Label wording

- **Tisagenlecleucel** (Kymriah), Acute lymphoblastic leukaemia, 2nd line: “Paediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kymriah-epar-product-information_en.pdf)
- **Tisagenlecleucel** (Kymriah), Large B-cell lymphoma, 3rd line+: “Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kymriah-epar-product-information_en.pdf)
- **Tisagenlecleucel** (Kymriah), Follicular lymphoma, 3rd line+: “Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kymriah-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/tisagenlecleucel