NDAORALCAPSULEPriority Review
Approved
Oct 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
CALQUENCE (acalabrutinib) by AstraZeneca is tyrosine kinase inhibitors [moa]. First approved in 2017.
Drug data last refreshed 2d ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CALQUENCE (acalabrutinib) is an oral tyrosine kinase inhibitor that selectively targets Bruton's tyrosine kinase (BTK), a key signaling molecule in B-cell malignancies. It is approved for chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), working by inhibiting BTK-dependent cell proliferation and survival. The drug represents a next-generation BTK inhibitor with improved selectivity compared to first-generation agents.
Peak10.0 years to LOE
CALQUENCE remains in peak commercial phase with sustained market presence in hematologic malignancies, supporting mid-to-large commercial teams focused on oncology specialization.
Mechanism of Action
Tyrosine Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab
Started Jan 2026
80 enrolled
Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Started Jan 2026
500 enrolled
Chronic Lymphocytic Leukemia
Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus
Started Dec 2025
50 enrolled
Chronic Lymphocytic Leukemia
A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain
Started Sep 2025
55 enrolled
Mantle-cell Lymphoma
A Study to Investigate the Sequencing Strategy of Pirtobrutinib After Disease Progression on First-line Acalabrutinib Treatment for Adult Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Started Jun 2025
0Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.