Brukinsa (zanubrutinib)
- Region
- 🇪🇺 EU
- Active substance
- zanubrutinib
- Company
- BeOne Medicines Netherlands B. V.
- Status
- Authorised
- Therapeutic area
- Waldenstrom Macroglobulinemia
- CHMP opinion
- Thu 22 Jul 2021
- EU approval
- Mon 22 Nov 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004978
- ATC
- L01EL03
- Official record
- www.ema.europa.eu
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). 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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.