# Axicabtagene ciloleucel

Axicabtagene ciloleucel (Yescarta, Kite Pharma EU B.V.) has 3 EU-approved indications in 2 tumour types.

## Approved indications

### Large B-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | DLBCL or HGBL only; First-line chemoimmunotherapy (relapsed within 12 months from completion or refractory) |
| None | Monotherapy | 3rd line+ | DLBCL or PMBCL only; After two or more lines of systemic therapy |

### Follicular lymphoma

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

## Products

### Yescarta

- Company: Kite Pharma EU B.V.
- Target: CD19-directed CAR T-cell therapy
- Class: Other antineoplastic agents
- ATC: L01XX70
- EU approval: 23 Aug 2018
- Label revised: 8 Jun 2026
- Status: orphan medicine, PRIME, advanced therapy
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/yescarta-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/yescarta-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/yescarta

Mechanism (SmPC section 5.1): Engineered autologous T cells bind CD19-expressing target cells, triggering activation, proliferation, and cytokine release, resulting in apoptosis and necrosis of target cells.

## Label wording

- **Axicabtagene ciloleucel** (Yescarta), Large B-cell lymphoma, 2nd line: “Yescarta is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yescarta-epar-product-information_en.pdf)
- **Axicabtagene ciloleucel** (Yescarta), Large B-cell lymphoma, 3rd line+: “Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yescarta-epar-product-information_en.pdf)
- **Axicabtagene ciloleucel** (Yescarta), Follicular lymphoma, 3rd line+: “Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yescarta-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/axicabtagene-ciloleucel