Zanubrutinib (Brukinsa)

==General information==
Class/mechanism: BTK inhibitor
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information.
==Diseases for which it is established==
*Chronic lymphocytic leukemia
*Waldenström macroglobulinemia
==Diseases for which it is used==
*Follicular lymphoma
*Mantle cell lymphoma
*Marginal zone lymphoma
==Patient drug information==
==History of changes in FDA indication==
===Chronic lymphocytic leukemia===
*2023-01-19: Approved for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (Based on SEQUOIACLL)
===Follicular lymphoma===
*2024-03-07: Granted accelerated approval with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. (Based on ROSEWOOD)
===Mantle cell lymphoma===
*2019-11-14: Accelerated approval for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. (Based on BGB-3111-AU-003 & BGB-3111-206)
===Marginal zone lymphoma===
*2021-09-14: Accelerated approval for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. (Based on MAGNOLIA and BGB-3111-AU-003)
===Waldenström macroglobulinemia===
*2021-08-31: Approved for adult patients with Waldenström’s macroglobulinemia (WM). (Based on ASPEN)
==History of changes in EMA indication==
===Chronic lymphocytic leukemia===
*2022-11-15: Extension of indication to include treatment of adult patients with chronic lymphocytic leukaemia (CLL). (Based on SEQUOIACLL & ALPINE)
===Follicular lymphoma===
*2023-10-12: CHMP approved new indication in combination with obinutuzumab for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
===Marginal zone lymphoma===
*2022-10-28: Extension of indication to include treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one-prior anti-CD20-based therapy. (Based on BGB-3111-AU-003 & MAGNOLIA)
===Waldenström macroglobulinemia===
*2021-11-22: Initial authorization as monotherapy for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy. (Based on ASPEN)
*2021-11-22: Initial authorization as monotherapy for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) in first line treatment for patients unsuitable for chemo-immunotherapy. (Based on ASPEN)
==Also known as==
*Code name: BGB-3111
*Brand name: Brukinsa
==References==
Category:Drugs
Category:Oral medications
Category:BTK inhibitors
Category:Chronic lymphocytic leukemia medications
Category:Follicular lymphoma medications
Category:Mantle cell lymphoma medications
Category:Marginal zone lymphoma medications
Category:Waldenström macroglobulinemia medications
Category:FDA approved in 2019
Category:EMA approved in 2021