Zanubrutinib (Brukinsa)
Revision as of 18:27, 11 July 2022 by Jwarner (talk | contribs) (→History of changes in FDA indication)
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, UpToDate (courtesy of Lexicomp), or the prescribing information.
Diseases for which it is established (work in progress)
Diseases for which it is used
Patient drug information
History of changes in FDA indication
Mantle cell lymphoma
- 11/14/2019: 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
- 9/14/2021: 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
- 8/31/2021: Approved for adult patients with Waldenström’s macroglobulinemia (WM). (Based on ASPEN)
Also known as
- Code name: BGB-3111
- Brand name: Brukinsa