Small Lymphocytic Lymphoma (SLL) Treatments

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Brand Name

Brukinsa

Generic Name
Zanubrutinib
View Brand Information
FDA approval date: November 14, 2019
Classification: Kinase Inhibitor
Form: Tablet, Capsule

What is Brukinsa (Zanubrutinib)?

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma who have received at least one prior therapy.

Approved To Treat

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Related Clinical Trials

A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies
A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies
Enrollment Status: Recruiting
Publish Date: April 15, 2026
Intervention Type: Drug
Study Phase: Phase 1/Phase 2

Summary: The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R/R) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as oth...

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia
A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Enrollment Status: Recruiting
Publish Date: April 15, 2026
Intervention Type: Drug
Study Phase: Phase 3

Summary: The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).

A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab or Zanubrutinib Alone) vs. BCL-2 Inhibitor (Venetoclax) and Rituximab in Previously Untreated Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)
A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab or Zanubrutinib Alone) vs. BCL-2 Inhibitor (Venetoclax) and Rituximab in Previously Untreated Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)
Who is this study for: Patients with Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
Enrollment Status: Recruiting
Publish Date: April 13, 2026
Intervention Type: Biological, Procedure, Drug
Study Drugs: Ibrutinib, Rituximab, Venetoclax
Study Phase: Phase 2

Summary: This phase II trial studies the effects of venetoclax and rituximab in comparison to ibrutinib and rituximab or zanubrutinib in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called C...

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Successful treatment with zanubrutinib for Bing-Neel syndrome progressing on ibrutinib: a case report and literature review.
Successful treatment with zanubrutinib for Bing-Neel syndrome progressing on ibrutinib: a case report and literature review.
Journal: Leukemia & lymphoma
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Bruton protein-tyrosine kinase (BTK) FDA-approved small molecule inhibitors used for the management of neoplastic and inflammatory disorders.
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Journal: Pharmacological research
Published: March 31, 2026
Precision targeting of BTK in chronic lymphocytic leukemia: computational insights into structural dynamics and the influence of mutations on BTK inhibitors through QM and MM studies.
Precision targeting of BTK in chronic lymphocytic leukemia: computational insights into structural dynamics and the influence of mutations on BTK inhibitors through QM and MM studies.
Journal: Journal of biomolecular structure & dynamics
Published: March 23, 2026
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Brand Information

BRUKINSA (zanubrutinib)
1DOSAGE FORMS AND STRENGTHS
Capsules: Each 80 mg capsule is a size 0, white to off-white opaque capsule marked with "ZANU 80" in black ink.
Tablets: 160 mg, blue, oval, film-coated tablets debossed with "zanu" on one side and functional scoring on the other side.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling:
  • Hemorrhage
  • Infections
  • Cytopenias
  • Second Primary Malignancies
  • Cardiac Arrhythmias
  • Hepatotoxicity, including DILI
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data in the WARNINGS AND PRECAUTIONS reflect exposure to BRUKINSA in nine monotherapy and 2 combination clinical trials, administered at 160 mg twice daily in 1608 patients and at 320 mg once daily in 121 patients. Among these 1729 patients, the median duration of exposure was 27.6 months, 78% of patients were exposed for at least 12 months, and 60% of patients were exposed for at least 24 months.
In this pooled safety population, the most common adverse reactions (≥30%), including laboratory abnormalities, were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of BRUKINSA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Hepatobiliary disorder: drug-induced liver injury
4DESCRIPTION
BRUKINSA (zanubrutinib) is a kinase inhibitor. The empirical formula of zanubrutinib is C
The molecular weight of zanubrutinib is 471.55 Daltons.
Zanubrutinib has the following structure:
Chemical Structure
Each BRUKINSA capsule for oral administration contains 80 mg zanubrutinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell contains edible black ink, gelatin, and titanium dioxide.
Each BRUKINSA tablet for oral administration contains 160 mg zanubrutinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating contains FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, titanium dioxide, and triacetin.
5PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information).
6PRINCIPAL DISPLAY PANEL - 80 mg Capsule Carton
NDC 72579-011-02
Brukinsa
80 mg
Swallow capsules whole.
120 capsules
PRINCIPAL DISPLAY PANEL - 80 mg Capsule Carton
7PRINCIPAL DISPLAY PANEL - 160 mg Tablet Carton
Rx only
Brukinsa
160 mg
Swallow tablets whole.
60 tablets
PRINCIPAL DISPLAY PANEL - 160 mg Tablet Carton