Difference between revisions of "Zanubrutinib (Brukinsa)"

Revision as of 12:05, 31 December 2022

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)

Waldenström macroglobulinemia

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)

History of changes in EMA indication

11/22/2021: Initial authorization

Also known as

Code name: BGB-3111
Brand name: Brukinsa

References

@@ Line 25: / Line 25: @@
 ===[[Waldenström macroglobulinemia]]===
 *8/31/2021: Approved for adult patients with [[Waldenström macroglobulinemia|Waldenström’s macroglobulinemia (WM)]]. ''(Based on ASPEN)''
+==History of changes in EMA indication==
+*11/22/2021: Initial authorization
 ==Also known as==
@@ Line 44: / Line 46: @@
 [[Category:FDA approved in 2019]]
+[[Category:EMA approved in 2021]]