Ibrutinib

(Imbruvica®)

Imbruvica®

Drug updated on 4/24/2024

Dosage FormCapsule (oral; 70 mg and 140 mg); Tablet (oral; 140 mg, 280 mg, 420 mg); Suspension (oral; 70 mg/mL)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).
  • Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
  • Indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
  • Indicated for the treatment of 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.

Latest News

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Summary
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  • Ibrutinib (Imbruvica) is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD). It shows lower response rates compared to Bendamustine Rituximab and bortezomib-dexamethasone, cyclophosphamide, rituximab regimens in WM but has a safety advantage due to less neuropathy and hematologic toxicities.
  • A total of 16 studies provided comparative effectiveness and safety data on Imbruvica against other treatments for various conditions including CLL/SLL, WM, cGVHD.
  • In treating cGVHD after other treatments, Imbruvica demonstrates a high overall response rate with manageable side effects. This effectiveness is evident across both pediatric and adult populations, indicating its broad applicability.
  • As a first-line treatment for CLL/SLL, Imbruvica exhibits significant efficacy with a high overall response rate as well as progression-free survival rates in real-world clinical settings, aligning closely with randomized clinical trial outcomes.
  • However, it carries a heightened risk of bleeding, posing a notable safety concern when compared to other regimens. Studies reveal an increased risk of infection associated with this drug, while it is not significantly associated with higher risks related to serious adverse events like anemia or thrombocytopenia, offering some advantages over others.
  • For relapsed/refractory or high-risk treatment naive patients suffering from CLL/SLL, including those without del17p mutation; the use of Imbruvica alone or in combination showed promising results suggesting strong efficacy in these settings.
  • The presence of the CXCR4MUT genetic marker impacts the patient's response to Imbruvica during their course through WM, highlighting the importance of personalized treatment approaches.
  • Despite its effectiveness in treating CLL/SLL, WM, and cGVHD; Imbruvica poses safety concerns due to increased risks of infection and bleeding. Thus, considering patient-specific factors including age, genomic features, and disease severity is essential.

Product Monograph / Prescribing Information

Document TitleYearSource
Imbruvica (ibrutinib) Prescribing Information.2024Pharmacyclics LLC, Sunnyvale CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of front-line treatment regimens for Waldenstrom macroglobulinaemia: a systematic review and meta-analysis. 2023Blood Cancer Journal
Prognostic models predicting overall survival of chronic lymphocytic leukemia (CLL) patients treated with ibrutinib-based therapies: a systematic review and meta-analysis. 2023Leukemia & Lymphoma
Efficacy and Safety of Ibrutinib for Chronic Graft-Versus-Host Disease: A Systematic Review.2023Asian Pacific Journal of Cancer Prevention
Molecular-Biology-Driven Frontline Treatment for Chronic Lymphocytic Leukemia: A Network Meta-Analysis of Randomized Clinical Trials.2023International Journal of Molecular Sciences
Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. 2022Drugs - Real World Outcomes
Targeted therapies in CLL/SLL and the cumulative incidence of infection: A systematic review and meta-analysis. 2022Frontiers in Pharmacology
Risk of bleeding associated with ibrutinib in patients with b-cell malignancies: a systematic review and meta-analysis of randomized controlled trials.2020Frontiers in Pharmacology
A network meta-analysis of maintenance therapy in chronic lymphocytic leukemia. 2020PLoS One
Risk of infection associated with ibrutinib in patients with B-Cell malignancies: a systematic review and meta-analysis of randomized controlled trials. 2020Clinical Lymphoma Myeloma and Leukemia
Ibrutinib as initial therapy in chronic lymphocytic leukemia: A systematic review and meta-analysis. 2020European Journal of Haematology
Comparative Efficacy of Acalabrutinib in Frontline Treatment of Chronic Lymphocytic Leukemia: A Systematic Review and Network Meta-analysis.2020Clinical Therapeutics
Novel Targeted Therapies for Chronic Lymphocytic Leukemia in Elderly Patients: A Systematic Review.2020Clinical Lymphoma, Myeloma & Leukemia
Treatment outcomes of novel targeted agents in relapse/refractory chronic lymphocytic leukemia: a systematic review and network meta-analysis.2019Journal of Clinical Medicine
Adverse drug events associated with ibrutinib for the treatment of elderly patients with chronic lymphocytic leukemia: A systematic review and meta-analysis of randomized trials. 2019Medicine
CXCR4 mutations affect presentation and outcomes in patients with Waldenström macroglobulinemia: A systematic review.2019Expert Review of Hematology
The magnitude of improvement in progression-free survival with targeted therapy in relapsed/refractory chronic lymphocytic leukemia based on prognostic risk category: a systematic review and meta-analysis.2019Leukemia & Lymphoma
Efficacy of Ibrutinib-Based Regimen in Chronic Lymphocytic Leukemia: A Systematic Review.2019Journal of Hematology

Clinical Practice Guidelines