Ibrutinib

(Imbruvica®)

Ibrutinib

Drug updated on 11/1/2024

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 Waldenstrms 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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  • This summary is based on the review of 20 systematic review(s)/meta-analysis(es). [1-20]
  • Chronic Graft-versus-Host Disease (cGVHD): Ibrutinib demonstrated an overall response rate (ORR) of 54%-78% in pediatric patients and 67%-76% in adult patients, offering long-lasting responses with manageable side effects.
  • Chronic Lymphocytic Leukemia (CLL): In real-world settings, patients treated with ibrutinib exhibited 12-month overall survival rates of 95%-96% and 18-month overall survival rates of 91%, along with progression-free survival (PFS) rates ranging from 89%-93%.
  • Waldenstrom Macroglobulinaemia (WM): The combination of ibrutinib and rituximab (IR) achieved a pooled response rate of 26% and a two-year PFS of 82%, which was lower than the response rates of bendamustine-rituximab (46%) and bortezomib-dexamethasone-cyclophosphamide-rituximab (33%).
  • Uncommon EGFR Mutations: Ibrutinib showed significant effectiveness in patients with high-risk genomic features in CLL, reinforcing its role as a treatment option for patients with del(17p), del(11q), and unmutated IGHV status.
  • Infection Risk: Ibrutinib was associated with a significantly increased risk of infections in patients with B-cell malignancies, with a pooled risk ratio of 1.34 for any grade infections and 1.35 for grade 3-5 infections.
  • Bleeding Incidence: The use of ibrutinib significantly raised the risk of overall bleeding (RR=2.56) and major bleeding (RR=2.08), particularly noted in patients with Chronic Lymphocytic Leukemia (CLL).
  • Adverse Effects in Chronic Graft-versus-Host Disease (cGVHD): Common adverse effects for patients treated with ibrutinib included pyrexia, diarrhea, abdominal pain, cough, nausea, and other symptoms, indicating a broad range of manageable side effects.
  • The studies included patients with B-cell malignancies, such as Chronic Lymphocytic Leukemia (CLL) and Waldenstrom Macroglobulinaemia (WM), as well as pediatric and adult populations with Chronic Graft-versus-Host Disease (cGVHD); ibrutinib demonstrated a high overall response rate (ORR) of 54%-78% in pediatric and 67%-76% in adult patients with cGVHD, indicating effective treatment across age groups and manageable side effects.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Safety profile of first-line targeted therapies in elderly and/or comorbid chronic lymphocytic leukaemia patients (unfit subpopulation). A systematic review and network meta-analysis2024Critical Reviews In Oncology/Hematology
Efficacy and Effectiveness Outcomes of Treatments for Double-Exposed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients: A Systematic Literature Review2024Cancer Medicine
Efficacy and safety of front-line treatment regimens for Waldenstrom macroglobulinaemia: a systematic review and meta-analysis2023Blood Cancer Journal
Efficacy and Safety of Ibrutinib for Chronic Graft-Versus-Host Disease: A Systematic Review2023Asian Pacific Journal Of Cancer Prevention : Apjcp
Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma2023Drugs - Real World Outcomes
Molecular-Biology-Driven Frontline Treatment for Chronic Lymphocytic Leukemia: A Network Meta-Analysis of Randomized Clinical Trials2023International Journal Of Molecular Sciences
Targeted therapies in CLL/SLL and the cumulative incidence of infection: A systematic review and meta-analysis2022Frontiers In Pharmacology
Chemotherapy for non-Hodgkin lymphoma in the hemodialysis patient: A comprehensive review2021Cancer Science
Comparison Between Venetoclax-based and Bruton Tyrosine Kinase Inhibitor-based Therapy as Upfront Treatment of Chronic Lymphocytic Leukemia (CLL): A Systematic Review and Network Meta-analysis2021Clinical Lymphoma, Myeloma & Leukemia
Risk of Infection Associated With Ibrutinib in Patients With B-Cell Malignancies: A Systematic Review and Meta-analysis of Randomized Controlled Trials2020Clinical Lymphoma, Myeloma & Leukemia
Risk of Bleeding Associated With Ibrutinib in Patients With B-Cell Malignancies: A Systematic Review and Meta-Analysis of Randomized Controlled Trials2020Frontiers In Pharmacology
Novel Targeted Therapies for Chronic Lymphocytic Leukemia in Elderly Patients: A Systematic Review2020Clinical Lymphoma, Myeloma & Leukemia
Mechanisms of ibrutinib resistance in chronic lymphocytic leukemia and alternative treatment strategies2020Expert Review Of Hematology
Ibrutinib as initial therapy in chronic lymphocytic leukemia: A systematic review and meta-analysis2020European Journal Of Haematology
Resistance-Associated Mutations in Chronic Lymphocytic Leukemia Patients Treated With Novel Agents2020Frontiers In Oncology
Comparison of acalabrutinib plus obinutuzumab, ibrutinib plus obinutuzumab and venetoclax plus obinutuzumab for untreated CLL: a network meta-analysis2020Leukemia & Lymphoma
Therapeutic options for steroid-refractory acute and chronic GVHD: an evolving landscape2020Expert Review Of Hematology
Health-related quality of life and economic burden of chronic lymphocytic leukemia in the era of novel targeted agents2020Current Medical Research And Opinion
A network meta-analysis of maintenance therapy in chronic lymphocytic leukemia2020Plos One
Comparative Efficacy of Acalabrutinib in Frontline Treatment of Chronic Lymphocytic Leukemia: A Systematic Review and Network Meta-analysis2020Clinical Therapeutics

Clinical Practice Guidelines