Zanubrutinib (Brukinsa)

General information

Class/mechanism: BTK inhibitor
Route: PO
Extravasation: n/a

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Diseases for which it is established (work in progress)

• Waldenström macroglobulinemia

Diseases for which it is used

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Marginal zone lymphoma

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