Brukinsa
What Brukinsa is used for
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). Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Brukinsa
- Active substance
- zanubrutinib
- Disease area
- Waldenstrom Macroglobulinemia
- Medicine group
- Antineoplastic agents
- ATC code
- L01EL03
- Marketing authorisation holder
- BeOne Medicines Netherlands B. V.
- Authorised in the EU since
- 2021
Official information
In the USA
Same active substance: Brukinsa
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Brukinsa used for?
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). Brukinsa in combination with obinutuzumab is indicated for the treatment of adu…
What is the active substance in Brukinsa?
Brukinsa contains zanubrutinib.
Who makes Brukinsa?
The EU marketing authorisation holder is BeOne Medicines Netherlands B. V..
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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