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PCI-32765 (Ibrutinib)
Ibrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK) that blocks B-cell receptor signaling and reduces proliferation of malignant B cells.
Ibrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK) that blocks B-cell receptor signaling and reduces proliferation of malignant B cells. Used for Chronic lymphocytic leukemia (CLL), Mantle cell lymphoma (MCL), Marginal zone lymphoma (MZL).
At a glance
| Generic name | PCI-32765 (Ibrutinib) |
|---|---|
| Also known as | IMBRUVICA |
| Sponsor | Janssen Research & Development, LLC |
| Drug class | BTK inhibitor |
| Target | BTK (Bruton's tyrosine kinase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Ibrutinib covalently binds to and inhibits BTK, a key enzyme in B-cell receptor signaling pathways. By blocking BTK, the drug prevents activation and proliferation of B cells, leading to apoptosis of malignant B-cell lymphomas and leukemias. This mechanism is particularly effective in B-cell malignancies that depend on BCR signaling for survival.
Approved indications
- Chronic lymphocytic leukemia (CLL)
- Mantle cell lymphoma (MCL)
- Marginal zone lymphoma (MZL)
- Waldenstrom macroglobulinemia (WM)
Common side effects
- Diarrhea
- Fatigue
- Nausea
- Infections
- Hemorrhage
- Atrial fibrillation
- Thrombocytopenia
Key clinical trials
- Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma (PHASE2)
- Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma (PHASE1)
- Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia (PHASE2)
- Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (PHASE3)
- Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (PHASE2)
- Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (PHASE3)
- Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery (PHASE1)
- Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia (PHASE3)
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 |