Mantle cell lymphoma (MCL) is a rare type of non-Hodgkin lymphoma that affects B cells, a type of white blood cell (lymphocyte) that helps fight infections. In people with MCL, B cells grow and multiply out of control, forming tumors in the lymph nodes and sometimes spreading to areas such as the bone marrow, digestive tract, spleen, and liver.
If you or a loved one has MCL, you may be looking into treatment options. One medicine you might hear about is Beqalzi (sonrotoclax).
The FDA approved Beqalzi in May 2026 to treat adults with MCL that has come back after treatment (relapsed) or stopped responding to treatment (refractory).
Keep reading this article to learn how Beqalzi works for MCL, the typical dosage, and how it was studied. You may also be interested in reading about Beqalzi side effects and Beqalzi interactions.
How Does Beqalzi Work for Mantle Cell Lymphoma?
Normally, the body uses a natural process called apoptosis, or programmed cell death, to help damaged or abnormal cells self-destruct. Many cancer cells avoid this process by making high levels of proteins that help them survive and continue growing.
Some MCL cells have high levels of a protein called B-cell lymphoma 2 (BCL-2), which helps them stay alive longer than normal, making the cancer harder to treat. Beqalzi works by blocking this protein, which helps cancer cells self-destruct and die naturally.
Beqalzi is considered a targeted cancer treatment because it focuses on a specific protein involved in cancer cell survival. This targeted approach may help slow or stop the growth of mantle cell lymphoma cells, including in some people whose cancer has returned or stopped responding to other treatments.
Is Beqalzi Right for Me?
MCL can be difficult to treat because it may grow quickly in some people but more slowly in others. Your health care provider will recommend a treatment plan based on several factors, including your age, overall health, how aggressive the cancer is, and your Mantle Cell Lymphoma International Prognostic Index (MIPI) score.
The MIPI is a tool that helps estimate outlook and guide treatment decisions. It takes several factors into account, including your:
- Age
- Eastern Cooperative Oncology Group (ECOG) performance status, which is a scale that helps health care providers understand how well a person can carry out daily activities and tolerate cancer treatment
- Certain blood test results, including white blood cell count and lactate dehydrogenase (LDH) levels
To see if Beqalzi is right for you, your health care provider will also review the treatments you’ve previously received for your MCL.
Beqalzi is FDA-approved to treat adults with MCL that:
- Is relapsed (the cancer has come back after treatment) or refractory (stopped responding to treatment), and
- Has been previously treated with at least two systemic treatments, including a BTK inhibitor. (Systemic treatments are treatments that affect the whole body.)
A BTK inhibitor is a type of targeted cancer medicine commonly used for MCL. Examples include acalabrutinib, ibrutinib, pirtobrutinib, and zanubrutinib.
How Was Beqalzi Studied for Mantle Cell Lymphoma?
Beqalzi was studied in adults with mantle cell lymphoma (MCL) that had either returned after treatment or stopped responding to treatment.
The study enrolled people who had already received certain previous treatments for MCL. People also needed to meet certain health requirements before starting the study, such as minimum blood cell counts and liver function levels.
Some people were not allowed to join the trial. This included people whose lymphoma had spread to the brain or spinal cord, those who had previously received a BCL-2 inhibitor, and those with poor overall physical functioning.
The study included 103 adults. The median (midpoint) age was 68 years, with ages ranging from 39 to 85 years. Most participants were male (74%). Regarding race and ethnicity, 58% of participants were White, 33% were Asian, and 3% were Black or African American.
When the study began, most participants were able to carry out normal daily activities with little or no assistance. Researchers measured this using a standard scale called the ECOG performance status, and 93% of participants had scores showing relatively good physical functioning.
In terms of how aggressive the participants’ MCL was, about one-third of participants were considered low risk, one-third were intermediate risk, and nearly one-third were high risk according to the simplified MIPI.
The people enrolled in the trial had heavily pretreated disease:
- Participants had received a median of three previous lines of therapy, with some receiving as many as eight prior treatments.
- Nearly 9 out of 10 participants had already received at least two previous treatments, and 60% had received at least three.
- All participants had previously been treated with at least one BTK inhibitor. The most common were ibrutinib, zanubrutinib, and pirtobrutinib.
- Some people had also received other treatments, including other medicines, stem cell transplant, or CAR-T therapy.
This was a single-arm clinical trial, which means all participants received Beqalzi; no other treatment was used for comparison. After gradually increasing the dose during a ramp-up period, participants took Beqalzi once daily.
The main goal of the study was to see how many people responded to treatment and how long those responses lasted.
What Are the Main Benefits of Beqalzi Based on Studies?
Overall, 52% of study participants responded to Beqalzi treatment. Complete responses, meaning no detectable signs of cancer, occurred in 16% of people, while 37% had a partial response.
Among those who responded, the median duration of response was 15.8 months. The median time to see a response to treatment was about 1.9 months.
Your results may differ from those seen in studies.
Note that Beqalzi received accelerated approval from the FDA based on how many people responded to treatment and how long those responses lasted. Continued approval may depend on future studies confirming the benefits of Beqalzi for MCL.
How Do I Take Beqalzi?
Beqalzi is typically taken by mouth once daily with a meal, around the same time each day. The tablets should be swallowed whole with a glass of water. Do not crush, chew, or break the tablets.
When you first start Beqalzi, your dose will increase slowly over about four weeks before you reach your regular daily dose. This gradual “ramp-up” schedule helps lower the risk of a serious side effect called tumor lysis syndrome (TLS), which can happen when cancer cells break down too quickly. A starter pack is used during this early treatment phase to help guide the dosing schedule.
Your health care provider will monitor you closely during treatment with blood tests and other lab work, especially when you first start Beqalzi or if your dose changes. In some cases, treatment may need to be paused, restarted at a lower dose, or adjusted because of side effects or interactions with other medicines.
It is important to take Beqalzi exactly as prescribed and not restart treatment on your own after stopping it. Depending on how long treatment was interrupted, your health care provider may need to restart you at a lower dose using a special restart pack. Do not change your dose unless your health care provider tells you to. Always follow the instructions from your care team.
What Are Other Unique Considerations to Be Aware Of?
During Beqalzi treatment, your health care provider may monitor you closely with blood tests to watch for a serious condition called tumor lysis syndrome (TLS). You may also be asked to drink extra fluids, especially during the first several weeks of treatment, to help lower your risk of TLS. Some people may need to start treatment in a hospital or medical office so they can be monitored more closely.
Beqalzi may not be safe during pregnancy or breastfeeding and may affect fertility. Talk with your health care provider about pregnancy prevention, family planning, or breastfeeding before starting treatment with Beqalzi.
Tell your health care provider about all medicines, vitamins, and supplements you use before starting Beqalzi. You should also avoid grapefruit products, Seville oranges, and star fruit while taking this medicine.
Is There Any Cost Assistance Available for Beqalzi?
A cost assistance program may be available for Beqalzi from BeOne Medicines. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured. Visit this website to see if you are eligible for copay savings. You can also call 833-234-4363 to speak with someone about financial support options.
