Zanubrutinib (Brukinsa)

General information

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

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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

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 SEQUOIA_CLL)

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 SEQUOIA_CLL & 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, or in first line treatment for patients unsuitable for chemo-immunotherapy. (Based on ASPEN)

Also known as

• Code name: BGB-3111
• Brand name: Brukinsa