Beqalzi (sonrotoclax)
An approved treatment for Mantle Cell Lymphoma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Sonrotoclax wherever you encounter it, plus the key facts at a glance.
- Generic name
- Sonrotoclax
- Brand name
- Beqalzi
- Development code
- BGB-11417
- Drug class
- BCL-2 inhibitor
- Manufacturer
- BeOne Medicines (formerly BeiGene)
- How it's taken
- Oral tablet once a day after a 4-week ramp-up
A once-daily pill for adults whose mantle cell lymphoma came back or stopped responding after at least 2 earlier treatments, including a BTK inhibitor. The FDA granted it accelerated approval on May 13, 2026, and 52% of patients in its trial responded.
We'll email you when Beqalzi's FDA label changes, when the FDA acts on it, and when new trials for Mantle Cell Lymphoma open. Unsubscribe anytime.
- Trial Alerts, when a new trial opens or a trial changes
- Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
We never share your email. Unsubscribe anytime. Privacy policy · Check any health site
Where Sonrotoclax fits
For mantle cell lymphoma that has come back after at least 2 treatments, including a BTK inhibitor. Other approved options at that stage include Jaypirca and the CAR T-cell therapies Breyanzi and Tecartus. No trial has compared them.
How Sonrotoclax works
BCL-2 is a protein that keeps cells alive, and cancers that make too much of it resist dying and resist chemotherapy. Sonrotoclax binds BCL-2 and frees the proteins that set off programmed cell death, so the lymphoma cells die[1]. Because it can kill many cancer cells quickly, treatment starts with a 4-week ramp-up to lower the risk of tumor lysis syndrome[1].
Side effects and safety
- Tumor lysis syndrome. In 7% of patients who followed the ramp-up, as early as 4 hours after a dose, at each dose increase and on restart; prevented with fluids, a medicine that lowers uric acid and close blood tests.
- Serious infections. Serious in 14%, grade 3 or worse in 17% and fatal in 2.6%, most often pneumonia.
- Low neutrophils. Grade 3 or 4 in 18% (grade 4 in 6%); blood counts checked throughout treatment.
- Pregnancy. Can harm an unborn baby; effective contraception is advised.
- Tumor lysis risk check and blood chemistry before the first dose and closely during the ramp-up
- Complete blood counts throughout treatment
- Signs of infection
Beqalzi has no boxed warning, but taking it with a strong CYP3A inhibitor is contraindicated when starting and during the ramp-up[1]. Its warnings are tumor lysis syndrome, a dangerous spill of contents from dying cancer cells, which occurred in 7% of 115 patients who followed the ramp-up and can begin within 4 hours of a dose; serious infections in 14%, fatal in 2.6%; grade 3 or 4 low neutrophils in 18%; and harm to an unborn baby[1].
In its trial the most common side effects were pneumonia (16%), fatigue (16%), swelling (14%), diarrhea (14%) and upper respiratory infection (12%). Fatal side effects occurred in 4.3%, including pneumonia (2.6%) and sudden death (1.7%), and 8% stopped treatment because of a side effect[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Sonrotoclax
Beqalzi starts with a 4-week ramp-up from a Starter Pack: 1mg a day on days 1 to 3, then 2mg, 5mg, 10mg, 20mg, 40mg, 80mg and 160mg, each for 3 or 4 days, and from week 5 the dose is 320mg (four 80mg tablets) once a day until the lymphoma progresses or side effects become unacceptable[1]. Tablets are swallowed whole with food and water, never broken, chewed or crushed.
Before the first dose, the care team checks tumor lysis risk, starts fluids and a medicine that lowers uric acid, corrects blood chemistry and watches blood tests closely, and people at high risk may be monitored in the hospital[1].
Availability and cost
Only available as the brand-name product.
Help paying for Beqalzi
The maker of Beqalzi publishes no copay card, but its support program can check your insurance and explain any help that exists. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 3 charity funds for Mantle Cell Lymphoma, 3 were open on October 26, 2026. Pick your insurance below to see which offers fit you.
- Insurance and case manager help
Oncology Nurse Advocates help with insurance verification and connect eligible patients with the program's co-pay support, bridge supply and free product assistance. Call 1-833-234-4363, Monday to Friday, 8 AM to 8 PM ET.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: The Beqalzi page of myBeOne Support lists co-pay support, bridge supply and free product assistance without amounts, caps or eligibility rules, so only the hub is recorded. Checked on November 2, 2026.
Charity funds for Mantle Cell Lymphoma
- From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)Clinical Trials Co-Pay Fund (all blood cancers) fundOpen
Pays for: Insurance premiums and treatment-related copays, deductibles and coinsurance, up to $3,500 per year. Requires health insurance (any kind).
- From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)Patient Aid Program fundOpen
Pays for: One-time $100 stipend for non-medical expenses (transportation, food, housing, utilities); no income or insurance requirement, up to $100 per year.
The foundation says: “CURRENT FUND STATUS: Open. Fund is currently Open.” - From a charity · HealthWell FoundationMantle Cell Lymphoma fundOpen
Pays for: Prescription copays; Medicare Part B premiums, up to $8,500 per year. Requires health insurance (any kind).
Access and eligibility
Adults with relapsed or refractory mantle cell lymphoma after at least 2 lines of systemic therapy, including a BTK inhibitor. The trial left out people with lymphoma in the brain or spinal cord and anyone who had already taken a BCL-2 inhibitor.
Source: myBeOne Support
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
BGB-11417-201 (NCT05471843) was a single-arm trial in 103 adults with relapsed or refractory mantle cell lymphoma who had already had an anti-CD20 treatment and a BTK inhibitor, a median of 3 earlier lines. Overall, 52% responded, 16% completely, and responses lasted a median of 15.8 months, with a median follow-up of 11.9 months[1]. The approval rests on response rate and how long responses lasted, so continued approval may depend on a confirmatory trial[1].
Development history
Explore Mantle Cell Lymphoma trials
Other Mantle Cell Lymphoma treatments
Common questions about Sonrotoclax
▸What is Sonrotoclax (Beqalzi)?
A once-daily pill for adults whose mantle cell lymphoma came back or stopped responding after at least 2 earlier treatments, including a BTK inhibitor. The FDA granted it accelerated approval on May 13, 2026, and 52% of patients in its trial responded.
▸How does Sonrotoclax work?
BCL-2 is a protein that keeps cells alive, and cancers that make too much of it resist dying and resist chemotherapy. Sonrotoclax binds BCL-2 and frees the proteins that set off programmed cell death, so the lymphoma cells die[1]. Because it can kill many cancer cells quickly, treatment starts with a 4-week ramp-up to lower the risk of tumor lysis syndrome[1].
▸What are the side effects of Sonrotoclax?
Beqalzi has no boxed warning, but taking it with a strong CYP3A inhibitor is contraindicated when starting and during the ramp-up[1]. Its warnings are tumor lysis syndrome, a dangerous spill of contents from dying cancer cells, which occurred in 7% of 115 patients who followed the ramp-up and can begin within 4 hours of a dose; serious infections in 14%, fatal in 2.6%; grade 3 or 4 low neutrophils in 18%; and harm to an unborn baby[1]. In its trial the most common side effects were pneumonia (16%), fatigue (16%), swelling (14%), diarrhea (14%) and upper respiratory infection (12%). Fatal side effects occurred in 4.3%, including pneumonia (2.6%) and sudden death (1.7%), and 8% stopped treatment because of a side effect[1].
▸How is Sonrotoclax taken?
Beqalzi starts with a 4-week ramp-up from a Starter Pack: 1mg a day on days 1 to 3, then 2mg, 5mg, 10mg, 20mg, 40mg, 80mg and 160mg, each for 3 or 4 days, and from week 5 the dose is 320mg (four 80mg tablets) once a day until the lymphoma progresses or side effects become unacceptable[1]. Tablets are swallowed whole with food and water, never broken, chewed or crushed. Before the first dose, the care team checks tumor lysis risk, starts fluids and a medicine that lowers uric acid, corrects blood chemistry and watches blood tests closely, and people at high risk may be monitored in the hospital[1].
▸Is Sonrotoclax FDA approved?
Yes, Sonrotoclax (Beqalzi) is FDA approved (2026) for the treatment of Mantle Cell Lymphoma.
▸Why does Beqalzi start with a 4-week ramp-up?
To lower the risk of tumor lysis syndrome, which happens when many cancer cells die at once and spill their contents into the blood[1].
How it works: the daily dose rises from 1mg to 160mg over 4 weeks, using a Starter Pack, and reaches 320mg from week 5.
In the trial: tumor lysis syndrome occurred in 7% of 115 patients who followed the ramp-up, and it can begin within 4 hours of a dose.
Prevention: fluids and a medicine that lowers uric acid begin before the first dose, with close blood tests, and people at high risk may be monitored in the hospital.
Source: Beqalzi prescribing information, September 2026.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- BeOne Medicines via DailyMed · 2026-09-28. Beqalzi (sonrotoclax) tablets prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff684558-e9cb-46de-a8bf-f4d79093df7a
- FDA · 2026-05-13. FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma
- FDA. Beqalzi approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220711
- BeOne Medicines. myBeOne Support for Beqalzi patients. https://www.mybeonesupport.com/beqalzi/patient/