CALQUENCE (acalabrutinib maleate) · AstraZeneca
Calquence is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is also approved for the treatment of mantle cell lymphoma (MCL) in patients who have received at least one prior therapy. Additionally, the drug is used in combination with bendamustine and rituximab for adults with previously untreated MCL who are ineligible for autologous hematopoietic stem cell transplantation.
How CALQUENCE Works
Acalabrutinib and its active metabolite function as small-molecule inhibitors of Bruton tyrosine kinase (BTK) by forming a covalent bond with a cysteine residue in the BTK active site. BTK is a critical signaling molecule in the B-cell antigen receptor and cytokine receptor pathways that regulate B-cell proliferation, trafficking, and adhesion. By blocking BTK enzymatic activity, the drug inhibits these downstream signaling pathways, thereby preventing the growth and survival of malignant B cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-10-31
- Patent Cliff
- 2036
- Revenue
- $1.0B (Q2-2026)
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
CALQUENCE Approval History
What CALQUENCE Treats
4 indicationsCALQUENCE is approved for 4 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Previously untreated mantle cell lymphoma in patients ineligible for autologous hematopoietic stem cell transplantation (in combination with bendamustine and rituximab)
- Mantle cell lymphoma in patients who have received at least one prior therapy
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
CALQUENCE Target & Pathway
ProTarget
A kinase essential for B-cell development and signaling. BTK inhibitors block B-cell receptor signaling, making them highly effective in B-cell malignancies like chronic lymphocytic leukemia and mantle cell lymphoma.
CALQUENCE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CALQUENCE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CALQUENCE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CALQUENCE
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
AstraZeneca's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07635511 AB-HLA-2026 | XFH2026-05 | Ph 3 | not yet recruiting | Acalabrutinib Maleate and Bortezomib for Patients With HLA Antibodies |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CALQUENCE FDA Label Details
Indications & Usage
FDA Label (PDF)CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). • For the treatment of adult patients with MCL who have received at least one prior therapy. • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with bendamustine and rituximab is indicated for the treat...
CALQUENCE Patents & Exclusivity
Patents (10 active)
Exclusivity
Pro Intelligence Preview
Deep insights for CALQUENCE
Revenue Insights
- • Q2-2026: $1.0B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 73 active patents
Trial Analysis
- • 112 total trials
- • Stage: Growth
Competitive Landscape
- • 16 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment