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OTC
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INN: zanubrutinib
Data updated: 2026-04-25
Available in:
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About This Product
User Reviews
Reviews reflect personal experiences and are not medical advice. Always consult your doctor.
Manufacturer
BeOne Medicines Ireland Limited
ATC Code
L01EL03
Source
EMA · EMEA/H/C/004978
(
ARTG
)
Waldenströms Macroglobulinaemia (WM),BRUKINSA is indicated for the treatment of adult patients with Waldenströms macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,Chronic Lymphocytic Leukaemia (CLL)/Small Lymphocytic Lymphoma (SLL),BRUKINSA is indicated as monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), including patients with deletion 17p and/or TP53 mutation.Mantle cell lymphoma (MCL),BRUKINSA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.,This indication was approved via the provisional approval pathway, based on objective response rate. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.,Marginal Zone Lymphoma (MZL),BRUKINSA is indicated for the treatment of adult patients with marginal zone lymphoma (MZL)
who have received at least one-prior anti-CD20-based therapy.,This indication was approved via the provisional approval pathway, based on objective response rate. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.