zanubrutinib
zanubrutinib: sourced relationships with 1 company · 45 clinical trials tracked · 2 FDA decisions.
zanubrutinib evidence translation
What we can confirm
2 FDA records · 45 tracked trials
What it means
What to watch
Prepared research question
How could zanubrutinib → ONC affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 2 study sponsors
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| BeOne Medicines Ltd. (ONC) Reported 2019-11-14 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (45)showing 10 most recent
A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia
Primary endpoint: Safety and Adverse Events (AEs)
ZEN-CLL - A Phase II Trial Evaluating Zanubrutinib in Elderly, Treatment-Naïve, CLL Patients
Primary endpoint: Progression-Free Survival (PFS)
MOZART MZL: A Randomized Phase II Study Evaluating Mosunetuzumab Alone and in Combination With Either Zanubrutinib or Polatuzumab Vedotin for the Treatment of Patients With Relapsed/Refractory Marginal Zone Lymphoma
Primary endpoint: Complete response rate (arm 1 versus arm 2)
A Phase Two Study of Venetoclax Plus Zanubrutinib in Newly Diagnosed CLL and After Front-Line Time-Limited Venetoclax-Based Therapy
Primary endpoint: Rate of undetectable minimal residual disease (uMRD) (Firstline Cohort)
A Phase II Study of MRD-guided Zanubrutinib, Obinutuzumab, and Sonrotoclax (BOSon) for Previously Untreated Transplant-ineligible Patients With Mantle Cell Lymphoma
Primary endpoint: evaluate BOSon
A Phase II Study of Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
Primary endpoint: Complete response post CAR-T
Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Primary endpoint: Progression free survival (PFS)
A Phase 2 Study of Emavusertib in Combination With an Approved Bruton Tyrosine Kinase Inhibitor in Patients With Chronic Lymphocytic Leukemia and Other B-cell Malignancies
Primary endpoint: Cohort 1: Undetectable Measurable Residual Disease (uMRD) Rate
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
Primary endpoint: Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)
Obinutuzumab, Zanubrutinib, and Lenalidomide as First-Line Therapy for Mantle Cell Lymphoma: A Prospective, Single-Arm, Open-Label, Multicenter Study
Primary endpoint: complete response rate (CR)
FDA Decisions2 records
Frequently asked questions
Which companies have sourced relationships with zanubrutinib?
zanubrutinib has dated SEC/FDA relationship records for BeOne Medicines Ltd..
How many clinical trials involve zanubrutinib?
BioSniper tracks 45 clinical trials involving zanubrutinib.
What is zanubrutinib's latest FDA decision?
The most recent tracked FDA decision for zanubrutinib is Approval for 1 INDICATIONS AND USAGE BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy. ( 1.1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Waldenström's macroglobulinemia (WM). ( 1.2 ) Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. ( 1.3 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.4 ) Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. ( 1.5 ) This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.1 Mantle Cell Lymphoma BRUKINSA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.2 Waldenström's Macroglobulinemia BRUKINSA is indicated for the treatment of adult patients with Waldenström's macroglobulinemia (WM) [see Clinical Studies (14.2) ] . 1.3 Marginal Zone Lymphoma BRUKINSA is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.3) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.4 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma BRUKINSA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [see Clinical Studies (14.4) ] . 1.5 Follicular Lymphoma BRUKINSA is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.5) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial., dated June 10, 2025.