Beqalzi

Beqalzi (sonrotoclax) is a prescription cancer medicine used to treat adults with mantle cell lymphoma (MCL) that has come back or has not responded to treatment.

Beqalzi is used for adults with relapsed or refractory mantle cell lymphoma after at least 2 previous lines of systemic treatment, including treatment with a Bruton’s tyrosine kinase (BTK) inhibitor.

Beqalzi is a BCL-2 inhibitor; BCL-2 is a protein that can help cancer cells survive. Beqalzi works by blocking BCL-2, which may help cancer cells die.

Beqalzi was granted FDA accelerated approval on May 13, 2026, for adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor. FDA approval was based on the medicine response rate and how long responses lasted. In the main clinical trial, 52% of patients responded to Beqalzi, and the median duration of response was 15.8 months. Continued approval may depend on results from confirmatory clinical trial(s).

Quick facts about Beqalzi

• Beqalzi is the brand name for sonrotoclax.
• It is used for adults with relapsed or refractory mantle cell lymphoma after 2 prior treatment lines, including a BTK inhibitor.
• Beqalzi tablets are taken once daily with a meal.
• The dose is slowly increased over 4 weeks.
• The main serious warning is tumor lysis syndrome.
• Common side effects include pneumonia, fatigue, swelling, diarrhea, and upper respiratory tract infection.
• Beqalzi is BCL-2 inhibitor

Beqalzi is used to treat adults with relapsed or refractory mantle cell lymphoma after at least 2 previous systemic therapies, including a BTK inhibitor.

Relapsed mantle cell lymphoma means the cancer has come back after treatment. Refractory mantle cell lymphoma means the cancer did not respond to treatment or stopped responding.

This medicine is not approved for use in children.

Take this medicine exactly as prescribed by your healthcare provider. Do not change your dose or stop taking this medicine unless your healthcare provider tells you to.

Beqalzi is taken by mouth once daily with a meal at about the same time each day. Swallow the tablets whole with a glass of water. Do not break, chew, or crush tablets.

Beqalzi treatment begins with a 4-week dose ramp-up to help reduce the risk of tumor lysis syndrome. After the ramp-up phase, the recommended target dose is 320 mg once daily, taken as four 80 mg tablets, until disease progression or unacceptable toxicity.

Your healthcare provider may delay, reduce, or stop this medicine if you have side effects, abnormal blood tests, or certain drug interactions.

Beqalzi dosage ramp-up schedule

The Beqalzi starter pack provides the tablets for the first 4 weeks of treatment. Individual restart packs may be used if Beqalzi has been stopped and needs to be restarted at a lower dose.

Tumor lysis syndrome

These tablets can cause serious or life-threatening tumor lysis syndrome (TLS). The fast breakdown of cancer cells causes TLS and can lead to kidney failure, abnormal heartbeat, seizures, or death. TLS may happen as early as 4 hours after the first dose, after a dose increase, or when restarting Beqalzi after a break in treatment.

Your healthcare provider will check your risk of TLS before you start this medicine and may give you medicines and fluids to help prevent TLS. You will need blood tests before and during treatment, especially during the 4-week dose ramp-up phase and when restarting treatment.

Drink water as directed by your healthcare provider. The recommended amount is usually 6 to 8 glasses, about 1.5 to 2 liters, each day starting 1 to 2 days before your first dose, on the day of your first dose, on any day your dose is increased until you reach the target dose, and when restarting treatment if needed.

Call your healthcare provider right away or get emergency medical help if you have symptoms of TLS, such as nausea, vomiting, diarrhea, muscle cramps, weakness or twitching, fatigue, decreased urination, swelling in your legs, ankles, or feet, numbness or tingling (especially around your mouth or in your hands and feet), confusion or difficulty staying alert, irregular or fast heart rate, or seizures.

Infections

This medicine can also cause serious infections, including fatal infections, and low white blood cell counts called neutropenia. Your healthcare provider will monitor you for infection and will check your blood counts during treatment.

Pregnancy warning

Beqalzi can harm an unborn baby. Females who can become pregnant and males with female partners who can become pregnant should use effective birth control during treatment and for 1 week after the last dose.

You should not take Beqalzi with a medicine that is a strong CYP3A inhibitor when starting Beqalzi or during the 4-week dose ramp-up phase.

Before taking this medicine, tell your healthcare provider about all your medical conditions, including if you:

• have kidney problems;
• have a history of high uric acid levels in your blood or gout;
• have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium;
• have liver problems;
• have an infection or have recently had an infection;
• have low blood counts;
• are pregnant or plan to become pregnant;
• are breastfeeding or plan to breastfeed.

Pregnancy and Breastfeeding

Your healthcare provider may do a pregnancy test before you start Beqalzi.

Females who can become pregnant should use effective contraception during treatment with this medicine and for 1 week after the last dose.

Males with female partners who can become pregnant should use effective contraception during treatment with this medicine and for 1 week after the last dose.

Do not breastfeed during treatment with this medicine and for 1 week after the last dose.

Beqalzi may affect fertility in females and males. Talk with your healthcare provider if this is a concern for you.

Common Beqalzi side effects

The most common side effects of Beqalzi include:

• pneumonia;
• fatigue;
• swelling;
• diarrhea;
• upper respiratory tract infection;
• fever;
• constipation;
• rash;
• muscle, bone, or back pain.

The most common severe or serious laboratory abnormalities include decreases in lymphocytes, hemoglobin, platelets, and neutrophils, and changes in blood chemistry

Other Beqalzi side effects reported in clinical studies included tumor lysis syndrome, headache, nausea, vomiting, mouth sores or inflammation, peripheral sensory neuropathy, febrile neutropenia, pneumonitis, herpes zoster infection, and sepsis.

Serious side effects

Get emergency medical help if you have symptoms of tumor lysis syndrome, including nausea, vomiting, diarrhea, muscle cramps, weakness or twitching, fatigue, decreased urination, swelling in your legs, ankles, or feet, numbness or tingling (especially around your mouth or in your hands and feet), confusion or difficulty staying alert, irregular or fast heart rate, or seizures.

Call your healthcare provider right away if you have signs of infection, such as fever, chills, cough, shortness of breath, burning or pain when you urinate, or other symptoms that concern you.

This medicine may cause serious side effects, including:

• tumor lysis syndrome;
• serious infections, including pneumonia;
• low white blood cell counts called neutropenia;
• harm to an unborn baby.

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

You may also report side effects to BeOne Medicines at 1-877-828-5596.

Usual adult dose for mantle cell lymphoma:

Start Beqalzi with the 4-week ramp-up schedule according to the table. Once the 4-week ramp-up schedule is complete, in Week 5, take 320 mg by mouth once daily. See the “Beqalzi dosage ramp-up schedule” above for the full 4-week dose increase schedule.

Use: treatment of adults with relapsed or refractory mantle cell lymphoma after at least 2 lines of systemic therapy, including a BTK inhibitor.

Tablets should be taken with a meal and a glass of water. Continue treatment until disease progression or unacceptable toxicity.

Dose interruptions, dose reductions, restart doses, or discontinuation may be needed for tumor lysis syndrome, low blood counts, infections, other serious side effects, or drug interactions. Follow your healthcare provider’s instructions.

If you miss a dose and it is within 8 hours of your usual time, take the missed dose as soon as possible with a meal. Then take your next dose at your regular time.

If you miss a dose by more than 8 hours, skip the missed dose. Take your next dose at your regular time the next day.

Do not take 2 doses at the same time to make up for a missed dose.

For dose interruption lasting greater than 7 days, adjust the restart Beqalz dose according to the prescribing information

Do not take an extra dose that day. Take your next dose at your regular time the next day.

Avoid grapefruit, grapefruit juice, Seville oranges, and star fruit during treatment withthis medicine. These products may interact with Beqalzi and increase your risk of side effects.

Do not start any new prescription medicine, over-the-counter medicine, vitamin, or herbal supplement without telling your healthcare provider. Some medicines can affect Beqalzi levels in your blood.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Beqalzi can interact with medicines that affect CYP3A enzymes. Some interactions can increase Beqalzi levels and raise the risk of side effects, including tumor lysis syndrome. Other interactions can lower Beqalzi levels and may make it less effective.

Do not take this medicine with a strong CYP3A inhibitor when starting treatment or during the ramp-up phase. Examples of strong CYP3A inhibitors may include certain antifungals, antibiotics, antivirals, or other medicines. Your healthcare provider may change your dose after the ramp-up phase if treatment with a strong or moderate CYP3A inhibitor is needed.

Avoid strong or moderate CYP3A inducers during treatment with Beqalzi.

Do not start or stop any medicine without asking your healthcare provider.

Beqalzi tablets are purple, film-coated tablets available in 1 mg, 5 mg, 20 mg, and 80 mg strengths.

Store tablets at room temperature, 68°F to 77°F (20°C to 25°C). Short temperature excursions are permitted between 59°F and 86°F (15°C to 30°C).

Store blister wallets in the original blister package. Do not transfer tablets from blister wallets into another container.

Beqalzi works by blocking BCL-2, a protein that can help some cancer cells survive. By inhibiting BCL-2, sonrotoclax can help trigger apoptosis, a process of programmed cell death, in cancer cells that depend on BCL-2 signaling.

Yes. Beqalzi was granted FDA accelerated approval for adults with relapsed or refractory mantle cell lymphoma after at least 2 lines of systemic therapy, including a BTK inhibitor. Accelerated approval means the medicine was approved based on response rate and durability of response; continued approval may depend on confirmatory trial results.

Beqalzi was evaluated in the BGB-11417-201 clinical trial (NCT05471843), in adults with relapsed or refractory mantle cell lymphoma (MCL). Patients in the study had previously received anti-CD20-based therapy and a Bruton’s tyrosine kinase (BTK) inhibitor.

In 103 patients evaluated for effectiveness, 52% responded to Beqalzi treatment. This included:

• 16% of patients who had a complete response, meaning no signs of cancer were detected using the study’s response criteria;
• 37% of patients who had a partial response, meaning their cancer decreased but did not completely disappear.

The median time to response was 1.9 months, meaning half of the patients who responded did so within about 2 months. The median duration of response was 15.8 months, after an estimated median follow-up of 11.9 months.

In 115 patients evaluated for safety, 37% had serious adverse reactions. Pneumonia was the most common serious adverse reaction reported in the study.