Breyanzi

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lisocabtagene maraleucel

Authorised
This medicine is authorised for use in the European Union.

Overview

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

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

Breyanzi can be used in patients whose cancer came back or did not respond after two or more previous treatments.

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 20/05/2022

Authorisation details

Product details
Name
Breyanzi
Agency product number
EMEA/H/C/004731
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
L01
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
04/04/2022
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

Breyanzi - EMEA/H/C/004731 -

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 relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy.

Assessment history

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