BRUKINSA (Zanubrutinib)
Selective Bruton Tyrosine Kinase (BTK) Inhibitor for B-Cell Malignancies
BRUKINSA (zanubrutinib) is a next-generation, highly selective Bruton tyrosine kinase (BTK) inhibitor used to treat several types of B-cell blood cancers. It works by irreversibly blocking BTK, a protein that cancer cells rely on for growth and survival. BRUKINSA is approved for chronic lymphocytic leukemia (CLL), Waldenström macroglobulinemia (WM), marginal zone lymphoma (MZL), and follicular lymphoma (FL, in combination with obinutuzumab). It is taken orally as capsules or tablets and requires a prescription. In head-to-head clinical trials, zanubrutinib has demonstrated a favorable efficacy and safety profile compared with earlier BTK inhibitors, particularly with lower rates of cardiovascular side effects.
Quick Facts: BRUKINSA
Key Takeaways
- BRUKINSA (zanubrutinib) is a highly selective BTK inhibitor that blocks a key signaling protein cancer cells need to grow, approved for CLL, Waldenström macroglobulinemia, marginal zone lymphoma, and follicular lymphoma.
- In the landmark ALPINE trial, zanubrutinib demonstrated superior response rates and significantly fewer cardiac side effects (particularly atrial fibrillation) compared with ibrutinib in relapsed/refractory CLL.
- The standard dose is 320 mg per day, taken either as 160 mg twice daily or 320 mg once daily; dose adjustments are required when used with certain CYP3A inhibitors or inducers.
- Key risks include bleeding events, infections (including hepatitis B reactivation), atrial fibrillation, low blood counts, and second primary malignancies; regular blood monitoring is essential throughout treatment.
- BRUKINSA must not be used during pregnancy; women of childbearing potential must use effective contraception during treatment and for at least one month after the last dose.
What Is BRUKINSA and What Is It Used For?
BRUKINSA contains the active substance zanubrutinib, a next-generation selective inhibitor of Bruton tyrosine kinase (BTK). BTK is a critical signaling enzyme in the B-cell antigen receptor (BCR) signaling pathway, which plays a central role in the development, differentiation, proliferation, and survival of B lymphocytes. In B-cell malignancies, the BCR pathway is often constitutively activated, driving the uncontrolled growth of cancerous B cells. By covalently and irreversibly binding to a specific cysteine residue (Cys481) in the ATP-binding site of BTK, zanubrutinib permanently inactivates the enzyme, disrupting the downstream signaling cascades—including NF-κB, MAPK, and PI3K/AKT pathways—that promote malignant cell growth, adhesion, migration, and survival.
What distinguishes zanubrutinib from earlier-generation BTK inhibitors, such as ibrutinib, is its enhanced selectivity for BTK. Ibrutinib inhibits several other kinases beyond BTK, including EGFR (epidermal growth factor receptor), ITK (interleukin-2–inducible T-cell kinase), and TEC family kinases. These off-target effects are believed to contribute to certain adverse events, particularly atrial fibrillation, rash, and diarrhea. Zanubrutinib was designed with optimized molecular pharmacology to minimize inhibition of these non-target kinases while maintaining potent and sustained BTK inhibition. At the recommended clinical dose, zanubrutinib achieves greater than 95% BTK occupancy in both peripheral blood mononuclear cells and lymph node tissue, ensuring deep and sustained target coverage.
Zanubrutinib is rapidly absorbed after oral administration, reaching peak plasma concentrations in approximately 2 hours. It is metabolized primarily by the cytochrome P450 enzyme CYP3A4, with a terminal half-life of approximately 2–4 hours. Despite this relatively short half-life, the irreversible binding to BTK means that the pharmacological effect persists far longer than the plasma presence of the drug, as BTK recovery requires new protein synthesis over 24–48 hours.
BRUKINSA has been approved by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and regulatory authorities worldwide for the following indications:
- Chronic lymphocytic leukemia (CLL): BRUKINSA is approved for adult patients with CLL who have not previously been treated, or whose disease has relapsed after or not responded to at least one prior therapy. CLL is one of the most common forms of leukemia in adults, involving the accumulation of abnormal B lymphocytes in the blood, bone marrow, and lymph nodes. The SEQUOIA trial demonstrated the efficacy of zanubrutinib in treatment-naïve CLL, and the ALPINE trial showed superior overall response rates compared with ibrutinib in the relapsed/refractory setting.
- Waldenström macroglobulinemia (WM): Also known as lymphoplasmacytic lymphoma, WM is a rare B-cell cancer characterized by the overproduction of immunoglobulin M (IgM) by malignant cells in the bone marrow. This excess IgM can cause hyperviscosity of the blood, leading to symptoms such as blurred vision, headache, and bleeding. BRUKINSA is used for patients whose disease has relapsed or has not responded to prior treatment, or who cannot receive chemoimmunotherapy. The ASPEN trial compared zanubrutinib with ibrutinib in WM, showing comparable efficacy with a significantly better safety profile.
- Marginal zone lymphoma (MZL): MZL is a type of indolent (slow-growing) non-Hodgkin lymphoma that arises from the marginal zone B cells. It can affect various organs including the stomach, spleen, salivary glands, thyroid, eyes, lungs, bone marrow, and blood. In MZL, the abnormal B cells multiply too quickly and live too long, potentially causing organ enlargement and various symptoms depending on the site of disease. BRUKINSA is approved for MZL patients whose disease has relapsed or has not responded to prior therapy.
- Follicular lymphoma (FL): FL is one of the most common types of indolent non-Hodgkin lymphoma, arising from follicular center B cells. Patients with FL have too many abnormal B lymphocytes accumulating in lymph nodes, spleen, and bone marrow. BRUKINSA is used in combination with obinutuzumab (an anti-CD20 monoclonal antibody) for patients whose disease has relapsed or has not responded to at least two prior lines of systemic therapy. This combination was approved based on the ROSEWOOD trial, which showed significant improvements in overall response rate.
BRUKINSA was specifically designed to improve upon first-generation BTK inhibitors. Its enhanced selectivity for BTK means fewer off-target effects, which translates to a better tolerability profile—particularly a lower incidence of atrial fibrillation, bleeding, and diarrhea. In the head-to-head ALPINE trial against ibrutinib, zanubrutinib demonstrated both superior efficacy and improved cardiac safety in patients with relapsed/refractory CLL.
What Should You Know Before Taking BRUKINSA?
Contraindications
BRUKINSA must not be used if you have a known hypersensitivity (allergy) to zanubrutinib or to any of the excipients listed in the product formulation. Signs of an allergic reaction may include an itchy, raised rash (hives), difficulty breathing, and swelling of the face, lips, tongue, or throat. If you experience any of these symptoms, stop taking BRUKINSA and seek immediate medical attention.
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before taking BRUKINSA if any of the following apply to you. These situations require special consideration and potentially closer monitoring during treatment.
Serious and fatal bleeding events have occurred in patients taking BRUKINSA. The mechanism involves BTK’s role in platelet function. Patients with an active hemorrhage or those receiving anticoagulant or antiplatelet therapy are at increased risk. If you have a history of abnormal bruising or bleeding, or if you are taking any medications or supplements that increase bleeding risk (aspirin, NSAIDs, warfarin, heparin, fish oil, vitamin E, flaxseed), tell your doctor. If you are scheduled for surgery, your doctor may ask you to stop BRUKINSA 3–7 days before and after the procedure.
- Irregular heartbeat (atrial fibrillation/flutter): If you have a history of irregular heartbeat, heart failure, or if you experience symptoms such as shortness of breath, weakness, dizziness, lightheadedness, fainting or near-fainting, chest pain, or swollen legs during treatment, tell your doctor immediately. Atrial fibrillation and flutter have been reported in patients taking BRUKINSA, though at lower rates than with ibrutinib.
- Infections: BRUKINSA affects the immune system and can increase your susceptibility to bacterial, viral, and fungal infections. These may include upper respiratory tract infections, pneumonia, urinary tract infections, and skin infections. Symptoms may include fever, chills, weakness, confusion, body aches, cold or flu-like symptoms, fatigue, shortness of breath, or yellowing of the skin or eyes (jaundice). Severe and potentially fatal opportunistic infections have been reported.
- Hepatitis B reactivation: If you have ever had hepatitis B, BRUKINSA could cause the virus to become active again. Your doctor will test you for hepatitis B before starting treatment and monitor you throughout therapy. If hepatitis B reactivation occurs, your doctor will stop BRUKINSA and initiate appropriate antiviral treatment.
- Low blood cell counts (cytopenias): BRUKINSA can cause decreased neutrophils (infection-fighting cells), platelets (clotting cells), and red blood cells. Your doctor will perform regular blood tests to monitor your blood counts before and during treatment and may occasionally prescribe additional medications or adjust your dose.
- Second primary malignancies: Other cancers, including skin cancers (basal cell carcinoma and squamous cell carcinoma), have been reported in patients treated with BRUKINSA. Use sunscreen and protect your skin from excessive sun exposure during treatment.
- Tumor lysis syndrome (TLS): The rapid breakdown of cancer cells can cause abnormal levels of chemicals in the blood, potentially affecting kidney function, heart rhythm, or causing seizures. Your doctor may perform blood tests to monitor for TLS, especially in patients with high tumor burden.
- Liver or kidney problems: If you have pre-existing liver or kidney disease, tell your doctor, as dose adjustments may be necessary. Hepatotoxicity, including elevated liver enzymes, has been reported.
- Recent surgery: If you have recently undergone surgery or plan to have surgery or dental procedures, tell your doctor. You may need to pause BRUKINSA for 3–7 days before and after the procedure to reduce bleeding risk.
Tests and Monitoring
Your doctor will perform regular blood tests before and during treatment with BRUKINSA. In the first weeks of treatment, you may notice an increase in white blood cell counts (lymphocytes) in your blood. This is a known pharmacological effect called lymphocytosis and does not mean your cancer is getting worse. It occurs because BRUKINSA displaces malignant B cells from the protective tissue microenvironment (lymph nodes, spleen) into the peripheral blood, where they eventually undergo apoptosis. Lymphocytosis typically resolves within the first few months of treatment.
Pregnancy and Breastfeeding
BRUKINSA must not be taken during pregnancy, as it may harm the unborn baby. Animal studies have indicated potential for developmental toxicity. If you are a woman of childbearing potential, your doctor will confirm you are not pregnant before starting treatment. You must use a highly effective method of contraception during treatment with BRUKINSA and for at least one month after the last dose. A barrier method of contraception (such as condoms) must be used in addition to hormonal contraceptives (such as the pill or intrauterine device), because it is not known whether BRUKINSA affects the efficacy of hormonal contraceptives.
If you become pregnant while taking BRUKINSA, tell your doctor immediately. You should not breastfeed while taking this medication, as zanubrutinib may pass into breast milk and could harm the nursing infant.
Driving and Operating Machinery
BRUKINSA may cause fatigue, dizziness, or weakness, which can affect your ability to drive or operate machinery safely. If you experience any of these symptoms after taking BRUKINSA, do not drive or use machines until you feel well enough to do so safely.
Children and Adolescents
BRUKINSA should not be used in patients younger than 18 years of age. The safety and efficacy of zanubrutinib in the pediatric population have not been established, and the drug is unlikely to be effective in childhood cancers due to the different biology of B-cell malignancies in children.
Important Information About Ingredients
BRUKINSA contains less than 1 mmol (23 mg) of sodium per dose, meaning it is essentially sodium-free. This is relevant for patients on a sodium-restricted diet.
How Does BRUKINSA Interact with Other Drugs?
Drug interactions with BRUKINSA are primarily driven by its metabolism through the CYP3A4 enzyme system. Medications that inhibit or induce CYP3A4 can significantly alter zanubrutinib plasma concentrations, affecting both efficacy and safety. Additionally, because zanubrutinib affects platelet function through BTK inhibition, concurrent use with anticoagulants or antiplatelet agents increases the risk of bleeding events. Always inform your doctor about all medications, herbal products, and supplements you are taking.
Major Interactions
| Interacting Drug | Effect | Clinical Action |
|---|---|---|
| Ketoconazole, posaconazole, vorikonazole (strong CYP3A4 inhibitors) | Markedly increased zanubrutinib plasma levels, greater toxicity risk | Reduce BRUKINSA dose to 80 mg once daily |
| Rifampicin, carbamazepine, phenytoin (strong CYP3A4 inducers) | Substantially decreased zanubrutinib levels, potentially reduced efficacy | Avoid combination; use alternative agents |
| Warfarin, heparin, DOACs (anticoagulants) | Increased risk of bleeding due to additive effects on hemostasis | Use with caution; monitor closely for bleeding signs |
| Aspirin, ibuprofen, naproxen (NSAIDs/antiplatelet agents) | Increased bleeding risk | Use with caution; inform doctor of all NSAID use |
Other Important Interactions
| Interacting Drug | Effect | Clinical Action |
|---|---|---|
| Fluconazole, erythromycin, ciprofloxacin, diltiazem (moderate CYP3A4 inhibitors) | Increased zanubrutinib levels | Reduce BRUKINSA dose to 80 mg twice daily |
| Efavirenz, modafinil (moderate CYP3A4 inducers) | Decreased zanubrutinib levels | Avoid if possible; efficacy may be reduced |
| Imatinib, aprepitant, fluvoxamine | Possible increase in zanubrutinib levels via CYP3A4 or other enzyme inhibition | Use with caution; monitor for increased side effects |
| Digoxin, pimozid, quinidine (narrow therapeutic index drugs) | Potential for altered drug levels | Monitor levels of co-administered drugs closely |
| Grapefruit, Seville oranges | Increased zanubrutinib levels via intestinal CYP3A4 inhibition | Avoid consumption during treatment |
| Fish oil, vitamin E, flaxseed (supplements) | May increase bleeding risk | Inform your doctor about all supplements |
Because zanubrutinib is primarily metabolized by CYP3A4, any drug that substantially affects this enzyme system has the potential to alter zanubrutinib exposure. Your oncologist or hematologist will carefully review all your medications before starting BRUKINSA and will advise you on any necessary dose adjustments or drug substitutions. It is critical that you do not start, stop, or change the dose of any medication without consulting your doctor first.
What Is the Correct Dosage of BRUKINSA?
BRUKINSA should always be taken exactly as prescribed by your doctor. The recommended total daily dose is 320 mg, which can be administered in two different schedules depending on your doctor’s preference, your specific indication, and any concurrent medications.
Adults
Standard Dosing
Dose: 320 mg per day
Schedule Option 1: 160 mg twice daily (morning and evening)
Schedule Option 2: 320 mg once daily
Formulations: Hard capsules (80 mg each) or film-coated tablets (160 mg each)
Capsules and tablets should be swallowed whole with a glass of water. They may be taken with food or between meals. Do not open, break, or chew the capsules. Take your doses at approximately the same time each day.
Dose Adjustment with CYP3A4 Inhibitors
With strong CYP3A4 inhibitors (ketoconazole, posaconazole, voriconazole): Reduce to 80 mg once daily
With moderate CYP3A4 inhibitors (fluconazole, erythromycin, ciprofloxacin): Reduce to 80 mg twice daily
When the CYP3A4 inhibitor is discontinued, resume the standard dose of 320 mg daily.
Follicular Lymphoma (in combination with obinutuzumab)
BRUKINSA dose: 320 mg daily (same as standard dosing)
Obinutuzumab: Administered by healthcare professional according to the obinutuzumab prescribing information
Treatment continues until disease progression or unacceptable toxicity.
Dose Modifications for Side Effects
Your doctor may temporarily pause, reduce, or permanently discontinue BRUKINSA depending on the type and severity of side effects you experience. Dose reductions typically follow a stepwise approach:
- First reduction: 80 mg twice daily (160 mg total daily)
- Second reduction: 80 mg once daily (80 mg total daily)
- If further reduction needed: Discontinuation of BRUKINSA
Children
BRUKINSA is intended for adult patients only. It should not be used in patients under 18 years of age, as the safety and effectiveness in the pediatric population have not been established.
Elderly
No specific dose adjustments are required for elderly patients based on age alone. However, elderly patients may be more susceptible to certain side effects, particularly infections and cardiac events. Your doctor will monitor you closely.
Missed Dose
If you miss a dose of BRUKINSA, take it at the next scheduled time and resume your normal dosing schedule. If you take BRUKINSA once daily, take your next dose the following day. If you take it twice daily (morning and evening) and miss the morning dose, take your next dose in the evening. Do not take a double dose to make up for a missed one. If you are unsure when to take your next dose, talk to your doctor, pharmacist, or nurse.
Overdose
If you take more BRUKINSA than prescribed, contact your doctor or emergency services immediately. Bring the medication packaging and this information with you. There is no specific antidote for zanubrutinib overdose; treatment is supportive.
Do not stop taking BRUKINSA unless your doctor tells you to. Stopping treatment prematurely could allow your cancer to progress. If you have any concerns about your treatment, discuss them with your doctor. BRUKINSA is typically taken continuously until the disease progresses or you experience intolerable side effects.
What Are the Side Effects of BRUKINSA?
Like all medicines, BRUKINSA can cause side effects, although not everyone experiences them. The overall tolerability profile of zanubrutinib has been shown to be favorable compared with first-generation BTK inhibitors in head-to-head clinical trials, particularly with significantly lower rates of atrial fibrillation and cardiac adverse events. However, awareness of potential side effects is important for early detection and management.
Itchy, raised rash (hives), difficulty breathing, or swelling of the face, lips, tongue, or throat – these may be signs of a serious allergic reaction to the medication.
Very Common
May affect more than 1 in 10 people
- Infections: upper respiratory tract infection, pneumonia, urinary tract infection (symptoms may include fever, chills, body aches, fatigue, cold/flu symptoms, shortness of breath, painful urination)
- Bruising and increased tendency to bruise
- Bleeding events (including nosebleed, blood in urine)
- Musculoskeletal and joint pain
- Diarrhea
- Cough
- Fatigue and weakness
- Rash
- High blood pressure (hypertension)
- Constipation
- Dizziness
- Low blood cell counts: neutropenia, thrombocytopenia, anemia (detected through blood tests)
Common
May affect up to 1 in 10 people
- Swollen hands, ankles, or feet (peripheral edema)
- Nosebleed (epistaxis)
- Itching (pruritus)
- Lower respiratory tract infection (lung infection)
- Small bleeding spots under the skin (petechiae)
- Rapid heart rate, missed heartbeats, weak or irregular pulse, dizziness, shortness of breath, chest discomfort (symptoms of cardiac rhythm problems, including atrial fibrillation)
- Weakness
- Febrile neutropenia (fever with low white blood cell counts)
Uncommon
May affect up to 1 in 100 people
- Hepatitis B reactivation (if you have previously had hepatitis B, it may return)
- Gastrointestinal bleeding (blood in stool)
- Tumor lysis syndrome (rapid cancer cell breakdown causing abnormal blood chemistry levels, potentially affecting kidney function, heart rhythm, or causing seizures)
Not Known
Frequency cannot be estimated from available data
- Generalized exfoliative dermatitis (skin redness and peeling over a large area of the body, which may be itchy or painful)
Lymphocytosis – An Expected Laboratory Finding
During the first weeks of treatment with BRUKINSA, blood tests may show an increase in white blood cells (lymphocytes). This is called treatment-related lymphocytosis and is an expected pharmacological effect of BTK inhibitors. It occurs because BRUKINSA disrupts the signals that keep malignant B cells anchored in the lymph nodes and spleen, causing them to be released into the bloodstream. This does not mean your cancer is getting worse. Lymphocytosis typically resolves within the first few months of treatment as the displaced cells gradually undergo cell death. Your doctor will monitor your blood counts and can explain what your results mean.
If you experience any side effects, including those not listed here, tell your doctor, pharmacist, or nurse. You can also report suspected side effects to your national pharmacovigilance authority (e.g., EMA in Europe, FDA MedWatch in the United States, MHRA Yellow Card Scheme in the United Kingdom) to help monitor the ongoing safety of BRUKINSA.
How Should You Store BRUKINSA?
Keep BRUKINSA out of the sight and reach of children. Do not use this medicine after the expiry date stated on the outer carton and on the bottle label after “EXP”. The expiry date refers to the last day of the stated month.
- Storage conditions: No special storage conditions are required for BRUKINSA capsules or tablets. Store at room temperature.
- Packaging: The capsules are supplied in a plastic bottle with a child-resistant closure. Each carton contains one bottle with 120 hard capsules.
- Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
What Does BRUKINSA Contain?
Active Substance
The active substance is zanubrutinib. BRUKINSA is available in two formulations:
- Hard capsules: Each capsule contains 80 mg of zanubrutinib
- Film-coated tablets: Each tablet contains 160 mg of zanubrutinib
Inactive Ingredients (Excipients)
Capsule contents:
- Microcrystalline cellulose
- Croscarmellose sodium
- Sodium lauryl sulfate (E487)
- Colloidal anhydrous silica (silicon dioxide)
- Magnesium stearate
Capsule shell:
- Gelatin
- Titanium dioxide (E171)
Printing ink:
- Shellac (E904)
- Black iron oxide (E172)
- Propylene glycol (E1520)
Appearance
BRUKINSA capsules are white to off-white hard capsules marked “ZANU 80” in black ink on one side. The capsules are supplied in a plastic bottle with a child-resistant closure. Each carton contains one bottle with 120 hard capsules.
Marketing Authorization Holder
BRUKINSA is marketed by BeiGene (through its subsidiary BeOne Medicines Ireland Ltd.). The marketing authorization holder in the EU is BeOne Medicines Ireland Ltd., Dublin, Ireland. The manufacturing site is BeOne Medicines I GmbH, Dutch Branch, Schiphol, Netherlands.
Frequently Asked Questions About BRUKINSA
BRUKINSA (zanubrutinib) is used to treat several types of B-cell blood cancers. It is approved for chronic lymphocytic leukemia (CLL) in both previously untreated and relapsed/refractory patients, Waldenström macroglobulinemia (WM) when prior treatment has failed or chemoimmunotherapy is not suitable, marginal zone lymphoma (MZL) after prior treatment failure, and follicular lymphoma (FL) in combination with obinutuzumab when prior treatments have not been effective. It works by blocking Bruton tyrosine kinase (BTK), an enzyme that cancer cells depend on for growth and survival.
BRUKINSA (zanubrutinib) is a next-generation BTK inhibitor designed to be more selective than ibrutinib, the first-in-class BTK inhibitor. In the head-to-head ALPINE trial for relapsed/refractory CLL, zanubrutinib showed a significantly higher overall response rate (80.4% vs. 72.9%) and significantly lower rates of atrial fibrillation (2.5% vs. 10.1%) compared with ibrutinib. The improved selectivity of zanubrutinib for BTK means less off-target inhibition of other kinases, resulting in fewer cardiac, gastrointestinal, and bleeding-related adverse events.
There is no specific prohibition on alcohol with BRUKINSA in the prescribing information. However, moderate alcohol consumption is generally advisable during cancer treatment. Alcohol can exacerbate certain side effects such as fatigue, dizziness, nausea, and gastrointestinal symptoms. Additionally, excessive alcohol may put additional strain on the liver, which is involved in metabolizing zanubrutinib. Discuss your alcohol intake with your doctor for personalized guidance.
BRUKINSA is typically taken continuously until the disease progresses or you experience side effects that are too severe to continue treatment. Unlike traditional chemotherapy, which is given in defined cycles, BTK inhibitor therapy is ongoing. Many patients take BRUKINSA for years. Your doctor will regularly assess your response to treatment and overall health to determine whether continued therapy is appropriate. Never stop taking BRUKINSA without first consulting your doctor.
Yes. Grapefruit and Seville oranges (bitter oranges) contain compounds called furanocoumarins that inhibit the CYP3A4 enzyme in the gut and liver. Since CYP3A4 is the primary enzyme responsible for metabolizing zanubrutinib, consuming grapefruit or its juice can increase the amount of BRUKINSA in your bloodstream, potentially increasing the risk and severity of side effects. It is best to avoid grapefruit products entirely during treatment.
If you need surgery or a dental procedure, inform your surgeon and your prescribing oncologist/hematologist well in advance. Your doctor will likely ask you to stop taking BRUKINSA for 3 to 7 days before the procedure and for a short period afterward, depending on the nature of the surgery and the risk of bleeding. This is because BRUKINSA affects platelet function and may increase surgical bleeding risk. Do not stop or restart BRUKINSA without explicit instructions from your doctor.
References
- European Medicines Agency (EMA). BRUKINSA (zanubrutinib) – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- U.S. Food and Drug Administration (FDA). BRUKINSA (zanubrutinib) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
- Brown JR, Eichhorst B, Hillmen P, et al. Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia (ALPINE). N Engl J Med. 2023;388(4):319–332. doi:10.1056/NEJMoa2211582.
- Tam CS, Opat S, D’Sa S, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. Blood. 2020;136(18):2038–2050. doi:10.1182/blood.2020006844.
- Tam CS, Quach H, Nicol A, et al. Zanubrutinib (BGB-3111) plus obinutuzumab in patients with chronic lymphocytic leukemia and follicular lymphoma. Blood Adv. 2020;4(19):4802–4811. doi:10.1182/bloodadvances.2020002611.
- Opat S, Tedeschi A, Engman J, et al. Zanubrutinib for the treatment of relapsed or refractory marginal zone lymphoma: the MAGNOLIA trial. Lancet Haematol. 2022;9(12):e903–e913. doi:10.1016/S2352-3026(22)00313-X.
- 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. doi:10.1016/S1470-2045(22)00293-5.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma. Version 1.2025.
- Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(1):23–33. doi:10.1016/j.annonc.2020.09.019.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
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This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in hematology, oncology, and clinical pharmacology.
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