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Zanubrutinib is the only BTK blocker to beat ibrutinib on both efficacy and safety in a head-to-head trial. It is now the most prescribed BTK inhibitor in CLL.
ALPINE (relapsed CLL): PFS superior to ibrutinib (HR 0.65) with less atrial fibrillation; SEQUOIA (frontline): PFS superior to bendamustine-rituximab, 5-year PFS 72% in del(17p); SEQUOIA arm D (zanubrutinib + venetoclax) uMRD ~60%. Approved in CLL January 2023. Also MCL, Waldenström, MZL, follicular lymphoma. BeOne is testing zanubrutinib + sonrotoclax (CELESTIAL-TNCLL) and the BTK degrader BGB-16673 as successors.
Covalent BTK inhibitor with sustained near-complete BTK occupancy in lymph nodes and fewer off-target kinases than ibrutinib. Connects to BTK (Bruton tyrosine kinase).
1.Twice-daily dosing keeps BTK occupancy >95% in nodes throughout the day
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Preferred BTK inhibitor on several commercial formularies.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA931 · SMC advice: zanubrutinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 6.8 years later, when the FDA's table was read.
Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 5.0 years later, when the FDA's table was read.
CLL/SLL source
Adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.5 years later, when the FDA's table was read. source
Formulation: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.3 years later, when the FDA's table was read.
Formulation: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.3 years later, when the FDA's table was read.
Formulation: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.3 years later, when the FDA's table was read.
| Region | Year | Indication |
|---|---|---|
| US | 2019 | Relapsed MCL (accelerated) |
| US | 2023 | CLL/SLL, all lines (SEQUOIA, ALPINE) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Atrial fibrillation/flutter | 5.2% | - |
| Neutropenia | - | 16% |
| Hypertension | 23% | - |
| Upper respiratory infection | 27% | - |
ALPINE vs 13.3% ibrutinib. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (btk inhibitors) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
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Evidence that the B-cell receptor pathway is worth attacking in follicular lymphoma when a Bruton tyrosine kinase inhibitor is paired with a type II CD20 antibody, after single-agent inhibitors had disappointed in this disease.
Zanubrutinib is an approved option for relapsed marginal zone lymphoma after anti-CD20 therapy, chosen for its tolerability profile.
ELEVATE-TN put a more selective BTK inhibitor into first-line CLL and, with the head-to-head ELEVATE-RR trial, showed it is as effective as ibrutinib with fewer cardiac side effects. Continuous acalabrutinib became one of the two main front-line options alongside fixed-duration venetoclax combinations. The trade-off is indefinite therapy and cost versus a time-limited course.
Query for this drug: (TITLE:"Zanubrutinib" OR ABSTRACT:"Zanubrutinib" OR TITLE:"Brukinsa" OR ABSTRACT:"Brukinsa") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Zanubrutinib, not a curated reading list.
Shares A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia, A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refrac, A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers., A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies.
Shares Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL), Caution: ibrutinib in patients with cardiac risk, A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia, CLL-IPI (chronic lymphocytic leukaemia prognostic index).
Shares Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL), ASPEN (Waldenström macroglobulinaemia), Caution: ibrutinib in patients with cardiac risk, ALPINE.
Shares Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL), Richter transformation, MIPI (Mantle Cell Lymphoma International Prognostic Index), BTK resistance mutations: C481S, and L528W and T474I after the non-covalent inhibitors.
Shares ROSEWOOD: a phase II randomized study of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma, ROSEWOOD, BTK resistance mutations: C481S, and L528W and T474I after the non-covalent inhibitors, BTK C481S, PLCG2 and BCL2 G101V resistance mutations.
Shares A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies, A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphom, CLL-IPI (chronic lymphocytic leukaemia prognostic index), CELESTIAL-TNCLL.
Shares Caution: chemoimmunotherapy in del(17p)/TP53 CLL, CLL-IPI (chronic lymphocytic leukaemia prognostic index), SEQUOIA, Relapsed or refractory chronic lymphocytic leukaemia.
Shares A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantl, MYD88 L265P and CXCR4 mutations, Nodal marginal zone lymphoma, Splenic marginal zone lymphoma.