Calquence (acalabrutinib)
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 Acalabrutinib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Acalabrutinib
- Brand name
- Calquence
- Development code
- ACP-196
- Drug class
- BTK inhibitor
- Manufacturer
- AstraZeneca
- How it's taken
- Oral tablet every 12 hours
A BTK inhibitor pill taken every 12 hours. For mantle cell lymphoma it is approved with bendamustine and rituximab for adults with untreated disease who cannot have an autologous stem cell transplant, and alone for adults who have had at least 1 earlier treatment. It is also approved for CLL and SLL.
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Where Acalabrutinib fits
Calquence and Brukinsa are the 2 covalent BTK inhibitors approved for mantle cell lymphoma, and Calquence is the one approved for untreated disease, with bendamustine and rituximab. Jaypirca, Beqalzi and CAR T-cell therapy are approved for later stages.
How Acalabrutinib works
BTK is a signaling enzyme in the B-cell receptor pathway that cancerous B cells use to grow and survive. Acalabrutinib binds permanently to BTK and switches it off, which slows the growth of mantle cell lymphoma cells[1].
Side effects and safety
- Infections. Serious or grade 3 or worse in 29% of 2,055 trial patients, most often respiratory infections, including pneumonia in 14%.
- Bleeding. Major bleeding in 4.7%, fatal in 0.1%; any bleeding apart from bruising in 39%. The label suggests weighing a 3 to 7 day pause around surgery.
- Low blood counts. Grade 3 or 4 low neutrophils in 28%; blood counts are checked regularly.
- Second cancers. In 16%, most often non-melanoma skin cancer (9%); sun protection is advised.
- Heart rhythm problems. Atrial fibrillation or flutter in 7%, grade 3 or 4 in 2.2%.
- Liver injury. Drug-induced liver injury has occurred; liver tests are checked during treatment.
- Complete blood counts regularly
- Liver tests during treatment
- Signs of infection, bleeding and irregular heartbeat
- Skin checks for new skin cancers
Calquence has no boxed warning. Its label warns about serious and opportunistic infections (serious or grade 3 or worse in 29% of 2,055 patients, most often respiratory infections, including pneumonia in 14%), bleeding (major bleeding in 4.7%, fatal in 0.1%), low blood counts (grade 3 or 4 low neutrophils in 28%), second cancers in 16% (most often skin cancers other than melanoma, 9%), atrial fibrillation or flutter in 7%, and liver injury[1].
The most common side effects, in 30% or more of patients, were upper respiratory infection, diarrhea, headache and musculoskeletal pain[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 Acalabrutinib
The dose is 100mg by mouth about every 12 hours, with or without food, swallowed whole with water and never chewed, crushed, dissolved or cut[1]. For untreated mantle cell lymphoma it starts on day 1 alongside 6 cycles of bendamustine and rituximab, and continues until the lymphoma progresses or side effects become unacceptable. A dose missed by more than 3 hours is skipped. Moderate CYP3A inhibitors lower the dose to 100mg once a day, and strong CYP3A inhibitors and inducers are avoided or need a dose change[1].
Availability and cost
Only available as the brand-name product.
Help paying for Calquence
With private insurance, the drugmaker's copay card can lower what you pay for Calquence. 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. People on Medicare may still qualify for the drugmaker's free medicine program. Without insurance, you can apply to the drugmaker's free medicine program, which sets its own eligibility rules. Pick your insurance below to see which offers fit you.
- Copay help
Calquence Co-pay Savings Program: people with commercial insurance may pay as little as $0 a month, up to the program maximum. Anyone whose prescription is paid by a state or federal program, such as Medicare, Medicaid, VA, DoD or TRICARE, is not eligible.
For: private insurance · source - Free medicine program
The AZ&Me Prescription Savings Program provides AstraZeneca medicines at no cost to people who qualify.
For: no insurance, Medicare · source - Insurance and case manager help
Access 360 helps with coverage and affordability. Call 1-844-ASK-A360 (1-844-275-2360), Monday to Friday, 8 AM to 6 PM ET, excluding holidays.
The official page does not say who qualifies. Ask the program. · source
Good to know: The Access 360 page does not state the annual program maximum; an older brochure listed $26,000 a year, which is not recorded. Free drug eligibility is decided by AZ&Me. 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).
Clinical trial results
ECHO (NCT02972840) randomly assigned 598 adults aged 65 or older with untreated mantle cell lymphoma and no plan for transplant to Calquence or placebo, each with bendamustine and rituximab. Median progression-free survival was 66.4 months with Calquence against 49.6 months with placebo (hazard ratio 0.73), and complete responses were 67% against 54%; overall survival had not reached its median in either group at that analysis[1].
In LY-004 (NCT02213926), a single-arm trial of 124 adults who had had at least 1 earlier treatment but no BTK inhibitor, 81% responded and 40% had a complete response[1].
Development history
The FDA first approved Calquence on October 31, 2017 for mantle cell lymphoma after at least 1 earlier treatment[2]. The label now also covers untreated mantle cell lymphoma with bendamustine and rituximab, based on ECHO, and CLL and SLL[1].
Explore Mantle Cell Lymphoma trials
Other Mantle Cell Lymphoma treatments
Common questions about Acalabrutinib
▸What is Acalabrutinib (Calquence)?
A BTK inhibitor pill taken every 12 hours. For mantle cell lymphoma it is approved with bendamustine and rituximab for adults with untreated disease who cannot have an autologous stem cell transplant, and alone for adults who have had at least 1 earlier treatment. It is also approved for CLL and SLL.
▸How does Acalabrutinib work?
BTK is a signaling enzyme in the B-cell receptor pathway that cancerous B cells use to grow and survive. Acalabrutinib binds permanently to BTK and switches it off, which slows the growth of mantle cell lymphoma cells[1].
▸What are the side effects of Acalabrutinib?
Calquence has no boxed warning. Its label warns about serious and opportunistic infections (serious or grade 3 or worse in 29% of 2,055 patients, most often respiratory infections, including pneumonia in 14%), bleeding (major bleeding in 4.7%, fatal in 0.1%), low blood counts (grade 3 or 4 low neutrophils in 28%), second cancers in 16% (most often skin cancers other than melanoma, 9%), atrial fibrillation or flutter in 7%, and liver injury[1]. The most common side effects, in 30% or more of patients, were upper respiratory infection, diarrhea, headache and musculoskeletal pain[1].
▸How is Acalabrutinib taken?
The dose is 100mg by mouth about every 12 hours, with or without food, swallowed whole with water and never chewed, crushed, dissolved or cut[1]. For untreated mantle cell lymphoma it starts on day 1 alongside 6 cycles of bendamustine and rituximab, and continues until the lymphoma progresses or side effects become unacceptable. A dose missed by more than 3 hours is skipped. Moderate CYP3A inhibitors lower the dose to 100mg once a day, and strong CYP3A inhibitors and inducers are avoided or need a dose change[1].
▸Is Acalabrutinib FDA approved?
Yes, Acalabrutinib (Calquence) is FDA approved (2017) for the treatment of Mantle Cell Lymphoma.
▸Is Calquence approved as a first treatment for mantle cell lymphoma?
Yes, with bendamustine and rituximab, for adults with untreated mantle cell lymphoma who cannot have an autologous stem cell transplant[1].
The trial: ECHO compared Calquence with placebo, each added to bendamustine and rituximab, in 598 adults aged 65 or older.
Results: median progression-free survival was 66.4 months with Calquence against 49.6 months with placebo, and complete responses were 67% against 54%.
Overall survival: the median had not been reached in either group at that analysis.
Source: Calquence prescribing information, October 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.
- AstraZeneca via DailyMed · 2026-10-16. Calquence (acalabrutinib) tablets prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1409184-3267-4d8c-8f17-4e01f69828b1
- FDA. Calquence approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210259
- AstraZeneca. Calquence patient affordability. https://www.myaccess360.com/patient/calquence-acalabrutinib/patient-affordability.html