Brukinsa

RSS

zanubrutinib

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

Overview

Brukinsa is a medicine for treating adults with the following types of blood cancers that affect a type of white blood cell called B lymphocytes or B cells:

  • Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic lymphoma). Brukinsa is used on its own in patients who have not been treated before and who cannot receive chemo-immunotherapy (a type of cancer treatment), or in patients who have received at least one prior therapy;
  • Marginal zone lymphoma (MZL). Brukinsa is used on its own when the disease has come back after at least one prior therapy targeting a protein on B lymphocytes called CD20;
  • Chronic lymphocytic leukaemia (CLL). Brukinsa is used on its own in patients for the treatment of CLL.

Brukinsa contains the active substance zanubrutinib.

This EPAR was last updated on 16/12/2022

Authorisation details

Product details
Name
Brukinsa
Agency product number
EMEA/H/C/004978
Active substance
zanubrutinib
International non-proprietary name (INN) or common name
zanubrutinib
Therapeutic area (MeSH)
Waldenstrom Macroglobulinemia
Anatomical therapeutic chemical (ATC) code
L01EL03
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
BeiGene Ireland Ltd
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
22/11/2021
Contact address

10 Earlsfort Terrace
Dublin D02 T380
Ireland

Product information

15/11/2022 Brukinsa - EMEA/H/C/004978 - II/0003

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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

Brukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

Brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.

Brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL).

Assessment history

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