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SUPERIOR RESPONSES WITH BRUKINSA + OBINUTUZUMAB vs OBINUTUZUMAB ALONE¹

69% of patients achieved a response with BRUKINSA + obinutuzumab compared with 46% with obinutuzumab alone¹
39% of patients achieved a CR with BRUKINSA + obinutuzumab compared with 19% with obinutuzumab alone¹
The median time to response in the BRUKINSA combination arm was 2.8 months (range: 2.0-23.0 months)¹

Median study follow-up: 20.2 months.²
Assessed by IRC.¹

CI=confidence interval; CR=complete response; IRC=independent review committee; ORR=overall response rate; PR=partial response.

~70% OF PATIENTS HAD SUSTAINED RESPONSES AT 18 MONTHS WITH BRUKINSA + OBINUTUZUMAB¹Patients Responding at 18 Months¹
(secondary endpoint)

Sustained responses at 18 months for BRUKINSA® (zanubrutinib) + obinutuzumab vs obinutuzumab al1

Estimated median follow-up for DOR: 19 months.¹
Assessed by IRC.¹

Median DOR for obinutuzumab monotherapy was 14 months while the median DOR for BRUKINSA + obinutuzumab has not yet been reached¹

CI=confidence interval; DOR=duration of response; IRC=independent review committee.

CONSISTENT RESPONSES ACROSS PATIENT SUBGROUPS²

All subgroup analyses are exploratory and descriptive in nature.
Median study follow-up: 20.2 months.²
Assessed by IRC.²

CI=confidence interval; FLIPI=Follicular Lymphoma International Prognostic Index; IRC=independent review committee; ITT=intent to treat.

28-MONTH MEDIAN PFS WITH BRUKINSA + OBINUTUZUMAB vs 10 MONTHS WITH OBINUTUZUMAB ALONE²Median PFS²
(secondary endpoint)*

28-month median PFS with BRUKINSA® (zanubrutinib) + obinutuzumab vs 10 months with obinutuzumab al1

*Analysis is descriptive in nature.
Assessed by IRC.²

BRUKINSA + obinutuzumab reduced the relative risk of progression or death by 50% vs obinutuzumab alone²

The median time to next treatment has not yet been reached with BRUKINSA + obinutuzumab vs 12 months with obinutuzumab²

CI=confidence interval; HR=hazard ratio; IRC=independent review committee; NE=not estimable; PFS=progression-free survival.

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IMPORTANT SAFETY INFORMATION

What should I tell my healthcare provider before taking BRUKINSA?

Before taking BRUKINSA, tell your healthcare provider about all of your medical conditions, including if you:

have bleeding problems.
have had recent surgery or plan to have surgery. Your healthcare provider may stop BRUKINSA for any planned medical, surgical, or dental procedure.
have an infection.
have or had heart rhythm problems.
have high blood pressure.
have liver problems, including a history of hepatitis B virus (HBV) infection.
are pregnant or plan to become pregnant. BRUKINSA can harm your unborn baby. If you are able to become pregnant, your healthcare provider may do a pregnancy test before starting treatment with BRUKINSA.

Females should avoid getting pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.
Males should avoid getting female partners pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.

are breastfeeding or plan to breastfeed. It is not known if BRUKINSA passes into your breast milk. Do not breastfeed during treatment with BRUKINSA and for 2 weeks after the last dose of BRUKINSA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking BRUKINSA with certain other medications may affect how BRUKINSA works and can cause side effects.

What are the possible side effects of BRUKINSA?

BRUKINSA may cause serious side effects, including:

Bleeding problems (hemorrhage). Bleeding problems are common with BRUKINSA, and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:

blood in your stools or black stools (looks like tar)
pink or brown urine
unexpected bleeding, or bleeding that is severe or you cannot control
vomit blood or vomit that looks like coffee grounds
cough up blood or blood clots
increased bruising
dizziness
weakness
confusion
change in speech
headache that lasts a long time

Infections that can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms.
Decrease in blood cell counts (white blood cells, platelets, and red blood cells). Your healthcare provider should do blood tests during treatment with BRUKINSA to check your blood counts.
Second primary cancers. New cancers have happened in people during treatment with BRUKINSA, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment with BRUKINSA. Use sun protection when you are outside in sunlight.
Heart rhythm problems (atrial fibrillation, atrial flutter, and ventricular arrhythmias) that can be serious and may lead to death. Tell your healthcare provider if you have any of the following signs or symptoms:

your heartbeat is fast or irregular
feel lightheaded or dizzy
pass out (faint)
shortness of breath
chest discomfort

Liver problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with BRUKINSA. Your healthcare provider will do blood tests to check your liver before and during treatment with BRUKINSA. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.

The most common side effects of BRUKINSA include:

decreased white blood cell count
decreased platelet count
upper respiratory tract infection
bleeding
muscle, bone, or joint pain

These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is BRUKINSA?

BRUKINSA is a prescription medicine used to treat adults 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 treatment for their cancer.
Marginal zone lymphoma (MZL) when the disease has come back or did not respond to treatment and who have received at least one certain type of treatment.
Follicular lymphoma (FL), in combination with the medicine obinutuzumab, when the disease has come back or did not respond to treatment and who have received at least two prior treatments.

It is not known if BRUKINSA is safe and effective in children.

Please see full Prescribing Information including Patient Information.

References: 1. BRUKINSA. Package insert. BeiGene USA, Inc.; 2025. 2. Zinzani PL, Mayer J, Flowers CR, et al. ROSEWOOD: a phase II randomized study of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma. J Clin Oncol. 2023;41(33):5107-5117.

Want to learn about a different indication?

CLL/SLL WM MCL MZL

BRUKINSA for FL The BRUKINSA Difference

Study Design Efficacy Safety

SUPERIOR RESPONSES WITH BRUKINSA + OBINUTUZUMAB vs OBINUTUZUMAB ALONE1