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.
1.Twice-daily dosing keeps BTK occupancy >95% in nodes throughout the day
- 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.
- Assistance programmes
- myBeiGene
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- 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.
- 19 Jan 2023ApprovalUS
CLL/SLL source
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductIbrutinib
Shares ALPINE, Caution: ibrutinib in patients with cardiac risk, ELEVATE-TN: acalabrutinib, alone or with obinutuzumab, against chemo-immunotherapy in untreated CLL, BTK inhibitor + venetoclax, fixed duration.
- ProductAcalabrutinib
Shares Caution: ibrutinib in patients with cardiac risk, ELEVATE-TN: acalabrutinib, alone or with obinutuzumab, against chemo-immunotherapy in untreated CLL, BTK inhibitor + venetoclax, fixed duration, Waldenström macroglobulinaemia.
- ProductSonrotoclax
Shares CELESTIAL-TNCLL, MRD-guided treatment duration in CLL, BTK inhibitor + venetoclax, fixed duration, BeOne Medicines (formerly BeiGene).
- ProductPirtobrutinib
Shares Richter transformation, Waldenström macroglobulinaemia, BTK (Bruton tyrosine kinase), Mantle cell lymphoma.
- ProductRituximab
Shares Caution: chemoimmunotherapy in del(17p)/TP53 CLL, SEQUOIA, Waldenström macroglobulinaemia, Mantle cell lymphoma.
- TrialCAPTIVATE
Shares MRD-guided treatment duration in CLL, BTK inhibitor + venetoclax, fixed duration, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia.
- ProductBGB-16673
Shares BeOne Medicines (formerly BeiGene), BTK (Bruton tyrosine kinase), Mantle cell lymphoma, Chronic lymphocytic leukaemia.
- Termdel(17p) / TP53 aberration in CLL
Shares Caution: chemoimmunotherapy in del(17p)/TP53 CLL, SEQUOIA, Mantle cell lymphoma, Chronic lymphocytic leukaemia.