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Calquence (ACALABRUTINIB)
Calquence (generic name: ACALABRUTINIB) is a Kinase Inhibitor [EPC] Small molecule drug developed by AstraZeneca. It is currently FDA-approved (first approved 2017) for Chronic lymphocyticleukemia/small lymphocytic lymphoma, Mantle cell lymphoma.
Calquence works by blocking the activity of the BTK enzyme, which is essential for the activation and survival of B cells.
Calquence, also known as Acalabrutinib, is a medication used to treat Mantle Cell Lymphoma, Previously Untreated Chronic Lymphocytic Leukaemia, and Small Lymphocytic Lymphoma. It is often used in combination with other medications, such as Venetoclax and Rituximab, as seen in clinical trials.
At a glance
| Generic name | ACALABRUTINIB |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Kinase Inhibitor [EPC] |
| Target | Tyrosine-protein kinase BTK |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2017 |
| Annual revenue | 3100 |
Mechanism of action
Acalabrutinib is small-molecule inhibitor of Bruton tyrosine kinase (BTK). Acalabrutinib and its active metabolite, ACP-5862, form covalent bond with cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is signaling molecule of the cell antigen receptor (BCR) and cytokine receptor pathways. In cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, acalabrutinib inhibited BTK-mediated activation of downstream signaling proteins CD86 and CD69 and inhibited malignant B-cell proliferation and tumor growth in mouse xenograft models.
Approved indications
- Chronic lymphocyticleukemia/small lymphocytic lymphoma
- Mantle cell lymphoma
Common side effects
- Anemia
- Neutropenia
- Headache
- Diarrhea
- Fatigue
- Myalgia
- Bruising
- Thrombocytopenia
- Upper respiratory tract infection
- Nausea
- Abdominal pain
- Constipation
Key clinical trials
- Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL) (PHASE3)
- Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE2)
- A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy (PHASE2)
- A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM) (PHASE1,PHASE2)
- AQUALIS:QoL of CLL Patients Treated With Acalabrutinib in France, Retrospective Study Based on Data From PLATON Database
- A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma (PHASE2)
- Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors
- REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Calquence CI brief — competitive landscape report
- Calquence updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Calquence
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Related
- Drug class: All Kinase Inhibitor [EPC] drugs
- Target: All drugs targeting Tyrosine-protein kinase BTK
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chronic lymphocyticleukemia/small lymphocytic lymphoma
- Indication: Drugs for Mantle cell lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing