START STRONG WITH BRUKINSA

*Based on March 2025 New Patient Starts from IQVIA LAAD claims, SHS PTD claims, and CareSet claims data.1

BRUKINSA was designed to meet the challenges of BTK inhibition, including in adult patients with CLL2

SUPERIOR EFFICACY ACROSS LINES OF THERAPY2-4

CONSISTENT BENEFIT FOR ALL CLL PATIENT SUBGROUPS STUDIED

Superior PFS vs BR in patients without del(17p) with consistent benefit in the largest prospective study of 1L patients with del(17p)2,4

PFS results in 1L CLL for BRUKINSA® (zanubrutinib) vs BR
PFS results in 1L CLL for BRUKINSA® (zanubrutinib) vs BR

Median follow-up: 26.2 months for Cohort 1 and 30.5 months for Cohort 2 at the initial analysis; 61.2 months for Cohort 1 and 65.8 months for Cohort 2 at the long-term follow-ups.4-6

The only BTKi with superior
 efficacy vs ibrutinib in 2L, regardless
 of mutation status2,3

PFS and ORR results in 2L CLL for BRUKINSA® (zanubrutinib) vs ibrutinib
PFS and ORR results in 2L CLL for BRUKINSA® (zanubrutinib) vs ibrutinib

Median follow-up: 31 months for PFS and 24.7 months for ORR at the initial analysis; 42.5 months for PFS and ORR at the long-term follow-up.1,2,7

All analyses are exploratory and descriptive in nature.

SEQUOIA was a global Phase 3, randomized, open-label, multicenter trial evaluating BRUKINSA vs BR in 479 patients with previously untreated CLL/SLL without del(17p). 110 patients with del(17p) were evaluated in a separate single-arm cohort and received BRUKINSA only. The primary endpoint was PFS per IRC in the ITT population in the BRUKINSA arm and the BR arm, with minimum 2-sided alpha of 0.05 for superiority.2,4

ALPINE was a global Phase 3, randomized, open-label, multicenter trial evaluating BRUKINSA vs ibrutinib in 652 patients with relapsed/refractory CLL/SLL who received ≥1 prior systemic therapy. Statistical analyses for PFS and ORR were initially conducted for noninferiority. When noninferiority was met, superiority was tested.2,3

1L=first line; 2L=second line; BR=bendamustine+rituximab; BTK=Bruton’s tyrosine kinase; BTKi=Bruton’s tyrosine kinase inhibitor; CI=confidence interval; CLL=chronic lymphocytic leukemia; HR=hazard ratio; IRC=independent review committee; ITT=intent to treat; ORR=overall response rate; PFS=progression-free survival; SLL=small lymphocytic lymphoma.

VIEW LONG-TERM EFFICACY DATA

CONSISTENTLY LOW RATES OF AFIB/FLUTTER
AND DISCONTINUATION ACROSS TRIALS

CONSISTENCY IN 2 GLOBAL PHASE 3 TRIALS

Safety results in 1L CLL for BRUKINSA® (zanubrutinib) vs BR

Median duration of treatment: 26.1 months for BRUKINSA and 5.6 months for BR in Cohort 1; 30.0 months for BRUKINSA in Cohort 2.4

Safety results in 2L CLL for BRUKINSA® (zanubrutinib) vs ibrutinib

Median duration of treatment: 28.4 months for BRUKINSA and 24.3 months for ibrutinib.3

Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury). In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).2

1L=first line; 2L=second line; AE=adverse event; afib=atrial fibrillation; BR=bendamustine+rituximab.

VIEW FULL SAFETY DATA

Dr Anthony Nguyen discusses how BRUKINSA has benefited his patients

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NCCN
PREFERRED

Zanubrutinib (BRUKINSA®) is a National Comprehensive Cancer Network® (NCCN®) preferred treatment option for patients with CLL8:

Without del(17p)/TP53

First-line: NCCN Category 1

Second-line: NCCN Category 1

With del(17p)/TP53

First-line: NCCN Category 2A

Second-line: NCCN Category 1

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 2, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage

Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients.

Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients.

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% of patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients.

Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.

Hepatotoxicity, Including Drug-Induced Liver Injury

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA.

Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

ADVERSE REACTIONS

The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

DRUG INTERACTIONS

CYP3A Inhibitors: When BRUKINSA is coadministered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

INDICATIONS

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:

  • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
  • Waldenström’s macroglobulinemia (WM)
  • Mantle cell lymphoma (MCL) who have received at least one prior therapy
  • Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
  • Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy

The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Please see full Prescribing Information.

References: 1. Data on file. BeiGene USA, Inc. 2. BRUKINSA. Package insert. BeOne Medicines USA, Inc.; 2025. 3. Brown JR, Eichhorst B, Hillmen P, et al. Zanubrutinib or ibrutinib in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2023;388(4):319-332. 4. Tam CS, Brown JR, Kahl BS, et al. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022;23(8):1031-1043. 5. Shadman M, Munir T, Robak T, et al. Zanubrutinib versus bendamustine and rituximab in patients with treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma: median 5-year follow-up of SEQUOIA. J Clin Oncol. 2025;43(7):780-787. 6. Tam CS, Ghia P, Shadman M, et al. SEQUOIA 5-year follow-up in arm C: frontline zanubrutinib monotherapy in patients with del(17p) and treatment-naive CLL/SLL [oral presentation]. Presented at: American Society of Clinical Oncology (ASCO) 2025 Annual Meeting; May 30-June 3, 2025. 7. Brown JR, Eichhorst B, Lamanna N, et al. Sustained benefit of zanubrutinib vs ibrutinib in patients with R/R CLL/SLL: final comparative analysis of ALPINE. Blood. 2024;144(26):2706-2717. 8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 2, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.