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Acalabrutinib is a cleaner BTK blocker with fewer heart and bleeding problems than ibrutinib. In February 2026 it became half of the first all-oral, fixed-duration CLL regimen.
ELEVATE-TN (frontline, 6-year median PFS not reached vs 27.8 months for chlorambucil-obinutuzumab; OS benefit for acalabrutinib-obinutuzumab), ELEVATE-RR (non-inferior PFS to ibrutinib with less atrial fibrillation), and AMPLIFY (acalabrutinib + venetoclax ± obinutuzumab, fixed duration: 3-year PFS 76.5%/83.1% vs 66.5% for chemoimmunotherapy) led to the 19 February 2026 approval of acalabrutinib-venetoclax for previously untreated CLL without del(17p)/TP53. Also approved in MCL (first-line 2025, ECHO). Tablet formulation removed the acid-suppressant interaction.
Highly selective covalent BTK inhibitor (C481) with minimal EGFR/TEC/ITK activity. Connects to BTK (Bruton tyrosine kinase).
1.Binds and inactivates BTK at C481 with high selectivity
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Calquence was selected for Medicare price negotiation in January 2025; the negotiated price takes effect 1 January 2027.
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Preferred BTK inhibitor on several commercial formularies.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap) · CMS: Medicare Drug Price Negotiation Program. Not medical or financial advice; verify with your plan.
Sources: NICE TA689 · SMC advice: acalabrutinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
CLL/SLL
Tablet formulation co-administrable with acid-reducing agents
Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
Confirmed: the accelerated approval of 2017 converted to traditional approval 7.2 years after it was granted.
Acalabrutinib + venetoclax fixed duration (AMPLIFY) source
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Relapsed MCL (accelerated) |
| US | 2019 | CLL/SLL, first-line and relapsed (ELEVATE-TN, ASCEND) |
| US | 2026 | Fixed-duration acalabrutinib + venetoclax, previously untreated CLL/SLL without del(17p)/TP53 (AMPLIFY) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Headache Mostly first weeks; responds to caffeine/paracetamol | 39% | - |
| Atrial fibrillation ELEVATE-RR vs 16% ibrutinib | 9% | - |
| Neutropenia With venetoclax (AMPLIFY) | - | 23% |
| Diarrhoea | 35% | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (btk inhibitors) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
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A second randomised confirmation that adding a Bruton tyrosine kinase inhibitor to first-line bendamustine-rituximab delays progression in older patients with mantle cell lymphoma, with a toxicity profile that did not improve as much as the drug's selectivity promised.
AMPLIFY delivered the first all-oral, fixed-duration doublet for front-line CLL and supported its approval, giving fit patients a way to avoid both chemotherapy and years of continuous BTK inhibitor. It does not settle whether a doublet or triplet is best, or how AV compares with venetoclax-obinutuzumab. Patients with TP53 aberration were excluded and still need different strategies.
ELEVATE-TN put a more selective BTK inhibitor into first-line CLL and, with the head-to-head ELEVATE-RR trial, showed it is as effective as ibrutinib with fewer cardiac side effects. Continuous acalabrutinib became one of the two main front-line options alongside fixed-duration venetoclax combinations. The trade-off is indefinite therapy and cost versus a time-limited course.
Query for this drug: (TITLE:"Acalabrutinib" OR ABSTRACT:"Acalabrutinib" OR TITLE:"Calquence" OR ABSTRACT:"Calquence") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Acalabrutinib, not a curated reading list.
Shares TEC, ITK, Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL), Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL).
Shares Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL), Caution: ibrutinib in patients with cardiac risk, A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia, CLL-IPI (chronic lymphocytic leukaemia prognostic index).
Shares Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL), MIPI (Mantle Cell Lymphoma International Prognostic Index), BTK resistance mutations: C481S, and L528W and T474I after the non-covalent inhibitors, BTK C481S, PLCG2 and BCL2 G101V resistance mutations.
Shares A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL, BTK resistance mutations: C481S, and L528W and T474I after the non-covalent inhibitors, ARCHED, BTK C481S, PLCG2 and BCL2 G101V resistance mutations.
Shares A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL), ELEVATE-TN, CLL-IPI (chronic lymphocytic leukaemia prognostic index).
Shares CLL-IPI (chronic lymphocytic leukaemia prognostic index), AMPLIFY, AMPLIFY: fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, versus chemo-immunotherapy in fit CLL patients, Richter transformation of chronic lymphocytic leukaemia.
Shares A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma, Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab, A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL).
Shares A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia, BTK inhibitor + venetoclax, fixed duration, BTK degraders to pre-empt resistance in frontline CLL, Relapsed or refractory chronic lymphocytic leukaemia.