# Lisocabtagene maraleucel

Lisocabtagene maraleucel (Breyanzi, Bristol-Myers Squibb Pharma EEIG) has 5 EU-approved indications in 3 tumour types.

## Approved indications

### Large B-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | DLBCL, HGBL or PMBCL only; Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy |
| 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 | 2nd line | Grade 3B only; Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy |
| None | Monotherapy | 3rd line+ | After two or more lines of systemic therapy |

### Mantle cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+ | After at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor |

## Products

### Breyanzi

- Company: Bristol-Myers Squibb Pharma EEIG
- Target: CD19-directed CAR T-cell therapy
- Class: Antineoplastic cell and gene therapy
- ATC: L01XL08
- EU approval: 4 Apr 2022
- Label revised: 6 Aug 2026
- Status: PRIME, advanced therapy
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/breyanzi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/breyanzi

Mechanism (SmPC section 5.1): CAR binding to CD19 on tumour and normal B cells activates CAR T cells, inducing proliferation, cytokine release, and cytotoxic killing of target cells.

## Label wording

- **Lisocabtagene maraleucel** (Breyanzi), Large B-cell lymphoma, 2nd line: “Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf)
- **Lisocabtagene maraleucel** (Breyanzi), Follicular lymphoma, 2nd line: “Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf)
- **Lisocabtagene maraleucel** (Breyanzi), Large B-cell lymphoma, 3rd line+: “Breyanzi is indicated for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf)
- **Lisocabtagene maraleucel** (Breyanzi), Follicular lymphoma, 3rd line+: “Breyanzi is indicated for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf)
- **Lisocabtagene maraleucel** (Breyanzi), Mantle cell lymphoma, 3rd line+: “Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/breyanzi-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/lisocabtagene-maraleucel