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Imbruvica (ibrutinib)
Imbruvica works by blocking the activity of a specific enzyme called Bruton's tyrosine kinase (BTK), which is involved in the growth and survival of cancer cells.
Imbruvica (ibrutinib) is a small molecule kinase inhibitor developed by Pharmacyclics Inc and currently owned by Pharmacyclics LLC. It targets the tyrosine-protein kinase Blk and has been FDA-approved since 2013 for various types of lymphomas and leukemias. Imbruvica is a patented medication with a half-life of 5 hours, and its commercial status is subject to change. Key safety considerations include potential bleeding risks and infections. Imbruvica is used to treat conditions such as chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenström macroglobulinemia.
At a glance
| Generic name | ibrutinib |
|---|---|
| Sponsor | AbbVie |
| Drug class | Kinase Inhibitor [EPC] |
| Target | Tyrosine-protein kinase Blk |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2013 |
| Annual revenue | 3200 |
Mechanism of action
Ibrutinib is small-molecule inhibitor of BTK. Ibrutinib forms covalent bond with cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTKs role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.
Approved indications
- Chronic graft-versus-host disease
- Chronic lymphoid leukemia, disease
- M lymphoplasmacytic
- Malignant lymphoma - small lymphocytic
- Mantle cell lymphoma
- Marginal zone lymphoma
- Waldenström macroglobulinemia
Common side effects
- Thrombocytopenia
- Diarrhea
- Fatigue
- Musculoskeletal pain
- Neutropenia
- Rash
- Anemia
- Bruising
- Muscle spasms
- Stomatitis
- Nausea
- Hemorrhage
Drug interactions
- amprenavir
- aprepitant
- atazanavir
- boceprevir
- carbamazepine
- ciclosporin
- cimetidine
- ciprofloxacin
- clarithromycin
- clozapine
- cobicistat
- conivaptan
Key clinical trials
- A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE3)
- Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL (PHASE3)
- A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (PHASE3)
- Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL) (PHASE2)
- Safety of PCI-32765 in Chronic Lymphocytic Leukemia (PHASE1,PHASE2)
- Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia (PHASE2)
- Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia (PHASE3)
- Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma (PHASE2)
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 |