Acalabrutinib
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.
1.Binds and inactivates BTK at C481 with high selectivity
- Route
- Oral
- Schedule
- 100 mg twice daily continuously (monotherapy), or 100 mg twice daily for 14 cycles with venetoclax added from cycle 3 (AMPLIFY fixed-duration)
- Monitoring
- Headache (early), infections, bleeding, atrial fibrillation (lower than ibrutinib), TLS with venetoclax
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- AstraZeneca Access 360
- AZ&Me Prescription Savings
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- Appraised for
- Untreated CLL (with 17p/TP53 or unsuitable for FCR/BR) and CLL after 1 prior therapy
- Notes
- Untreated mantle cell lymphoma with bendamustine-rituximab (ECHO) appraised 2025.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA689 · SMC advice: acalabrutinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 21 Nov 2019ApprovalUS
CLL/SLL
- 3 Aug 2022Label changeUS
Tablet formulation co-administrable with acid-reducing agents
- 19 Feb 2026ApprovalUS
Acalabrutinib + venetoclax fixed duration (AMPLIFY) source
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
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.
Latest papers
topQuery 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.