lisocabtagene maraleucel

This medicine is authorised for use in the European Union.


Breyanzi is a medicine used to treat adults with different types of cancer of white blood cells: 

  • diffuse large B-cell lymphoma (DLBCL); 
  • high-grade B-cell lymphoma (HGBCL); 
  • primary mediastinal large B-cell lymphoma (PMBCL); 
  • follicular lymphoma grade 3B (FL3B).

Breyanzi can be used in patients whose cancer came back (relapsed) or did not respond (refractory) after an initial treatment with chemoimmunotherapy (a combination of systemic therapy to kill or slow the growth of cancer cells and immunotherapy to stimulate or restore the immune system’s ability to fight the cancer). 

In patients with relapsed or refractory DLBCL, PMBCL or FL3B, it can also be used after two or more previous treatments with systemic therapy (treatment given by mouth or injection). 

Breyanzi is a type of advanced therapy medicine called a ‘gene therapy product’. This is a type of medicine that works by delivering genes into the body. 

Breyanzi contains lisocabtagene maraleucel, which is a combination of two types of genetically modified white blood cells.

This EPAR was last updated on 25/05/2023

Authorisation details

Product details
Agency product number
Active substance
  • CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells)
  • CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells)
International non-proprietary name (INN) or common name
lisocabtagene maraleucel
Therapeutic area (MeSH)
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Follicular
  • Mediastinal Neoplasms
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867

Product information

28/04/2023 Breyanzi - EMEA/H/C/004731 - II/0005

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

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