IMBRUVICA
Imbruvica (ibrutinib) is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and Waldenström’s macroglobulinemia (WM). It is also approved for adult and pediatric patients aged one year and older with chronic graft versus host disease (cGVHD) after the failure of one or more lines of systemic therapy. The indication for CLL and SLL includes patients with a 17p deletion.
How IMBRUVICA Works
Ibrutinib is a small-molecule inhibitor that targets Bruton’s tyrosine kinase (BTK) by forming a covalent bond with a cysteine residue in the enzyme's active site. This inhibition disrupts BTK’s role in signaling through the B-cell antigen receptor and cytokine receptor pathways, which are necessary for B-cell trafficking, chemotaxis, and adhesion. By blocking these pathways, the drug inhibits the proliferation and survival of malignant B-cells. It also prevents cell migration and substrate adhesion in B-cell populations.
Details
- Status
- Prescription
- First Approved
- 2013-11-13
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, TABLET, CAPSULE
IMBRUVICA Approval History
What IMBRUVICA Treats
5 indicationsIMBRUVICA is approved for 5 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Mantle Cell Lymphoma
- Chronic Lymphocytic Leukemia
- Waldenstrom Macroglobulinemia
- Marginal Zone Lymphoma
- Graft Versus Host Disease
IMBRUVICA Target & Pathway
ProTarget
A kinase essential for B-cell development and signaling. BTK inhibitors block B-cell receptor signaling, making them highly effective in B-cell malignancies like chronic lymphocytic leukemia and mantle cell lymphoma.
IMBRUVICA Competitors
Pro4 other drugs also target BTK. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (BTK). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IMBRUVICA FDA Label Details
ProIndications & Usage
FDA Label (PDF)IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) . Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion . Adult patients with Waldenström’s macroglobulinemia (WM) . Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy . 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with c...
IMBRUVICA Patents & Exclusivity
Patents (2678 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.