Brukinsa

zanubrutinib

Table of contents

Opinion

On 15 September 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Brukinsa. The marketing authorisation holder for this medicinal product is BeiGene Ireland Ltd.

The CHMP adopted a new indication for the treatment of marginal zone lymphoma (MZL). For information, the full indications for Brukinsa will therefore be as follows:1

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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold

Key facts

Name
Brukinsa
Agency product number
EMEA/H/C/004978
International non-proprietary name (INN) or common name
  • zanubrutinib
Active substance
  • zanubrutinib
Therapeutic area
Waldenstrom Macroglobulinemia
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.

Date opinion adopted
15/09/2022
Company name
BeiGene Ireland Ltd
Status
Positive
Application type
Post-authorisation

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