OnCo
drugsProductApproved2019🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

Zanubrutinib

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.

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Zanubrutinib
PubChem
Mechanism, step by step
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1.Twice-daily dosing keeps BTK occupancy >95% in nodes throughout the day

Modality
Small-molecule covalent BTK inhibitor (second generation)
Mechanism
Covalent BTK inhibitor with sustained near-complete BTK occupancy in lymph nodes and fewer off-target kinases than ibrutinib.
Brand / code
Brukinsa
Dosing & schedule
Route
Oral
Schedule
160 mg twice daily or 320 mg once daily, continuously
Monitoring
Infections, cytopenias, bleeding, atrial fibrillation (lower than ibrutinib), hypertension

Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.

Medicare
Part D (self-administered)

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).

Commercial insurance
covered with prior authorisation

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.

NICE recommendedNICE TA931 · 2023SMC: accepted
Appraised for
Untreated CLL (with 17p/TP53 or unsuitable for FCR/BR) and CLL after 1 prior therapy
Notes
Waldenström macroglobulinaemia: TA833 (2022). Relapsed or refractory mantle cell lymphoma and follicular lymphoma with obinutuzumab appraised 2024-25.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA931 · SMC advice: zanubrutinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 19 Jan 2023ApprovalUS

    CLL/SLL source

Approvals

RegionYearIndication
US2019Relapsed MCL (accelerated)
US2023CLL/SLL, all lines (SEQUOIA, ALPINE)

Safety

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Toxicity profile
Adverse eventAny gradeGrade 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.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
175 studies35 recruiting90 Phase 210 Phase 3
Search “Zanubrutinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Zanubrutinib
intervention: Zanubrutinib
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Key papers

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Latest papers

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Literature trend161 papers in the last 12 months+46% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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