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Acalabrutinib monotherapy
Acalabrutinib inhibits Bruton's tyrosine kinase (BTK), which blocks B-cell activation and proliferation.
Acalabrutinib inhibits Bruton's tyrosine kinase (BTK), which blocks B-cell activation and proliferation. Used for Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy, Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
At a glance
| Generic name | Acalabrutinib monotherapy |
|---|---|
| Also known as | Maintenance Phase |
| Sponsor | AstraZeneca |
| Drug class | Bruton's tyrosine kinase (BTK) inhibitor |
| Target | BTK |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
By selectively inhibiting BTK, acalabrutinib disrupts the B-cell receptor signaling pathway, leading to reduced survival and proliferation of malignant B cells, particularly in hematological cancers.
Approved indications
- Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
- Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma
Common side effects
- Headache
- Bruising
- Diarrhea
Key clinical trials
- A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain (PHASE2)
- A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-treatment Period (PHASE2)
- Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure (PHASE4)
- Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas (PHASE2)
- A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL (PHASE3)
- A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (PHASE3)
- A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies (PHASE1, PHASE2)
- Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL (PHASE2)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Acalabrutinib monotherapy CI brief — competitive landscape report
- Acalabrutinib monotherapy updates RSS · CI watch RSS
- AstraZeneca portfolio CI