Breyanzi
lisocabtagene maraleucel
Table of contents
Overview
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.
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List item
Breyanzi : EPAR - Medicine Overview (PDF/138.95 KB) (updated)
First published: 08/04/2022
Last updated: 25/05/2023
EMA/164279/2023 -
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Breyanzi : EPAR - Risk management plan summary (PDF/427.98 KB) (updated)
First published: 08/04/2022
Last updated: 25/05/2023
Authorisation details
Product details | |
---|---|
Name |
Breyanzi
|
Agency product number |
EMEA/H/C/004731
|
Active substance |
|
International non-proprietary name (INN) or common name |
lisocabtagene maraleucel
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01
|
Additional 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
|
Revision |
1
|
Date of issue of marketing authorisation valid throughout the European Union |
04/04/2022
|
Contact address |
Plaza 254 |
Product information
28/04/2023 Breyanzi - EMEA/H/C/004731 - II/0005
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.