Ibrutinib

(Imbruvica®)

Imbruvica®

Drug updated on 12/11/2024

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

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • 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 (relative risk (RR)=2.56) and major bleeding (RR=2.08), particularly noted in patients with CLL.
  • Adverse Effects in 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 CLL and Waldenstrom Macroglobulinaemia (WM), as well as pediatric and adult populations with cGVHD; ibrutinib demonstrated a high 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
Efficacy and Effectiveness Outcomes of Treatments for Double-Exposed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients: A Systematic Literature Review2024Cancer Medicine
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
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
Efficacy and Safety of Ibrutinib for Chronic Graft-Versus-Host Disease: A Systematic Review2023Asian Pacific Journal Of Cancer Prevention : Apjcp
Efficacy and safety of front-line treatment regimens for Waldenstrom macroglobulinaemia: a systematic review and meta-analysis2023Blood Cancer Journal
Targeted therapies in CLL/SLL and the cumulative incidence of infection: A systematic review and meta-analysis2022Frontiers In Pharmacology
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
Chemotherapy for non-Hodgkin lymphoma in the hemodialysis patient: A comprehensive review2021Cancer Science
Health-related quality of life and economic burden of chronic lymphocytic leukemia in the era of novel targeted agents2020Current Medical Research And Opinion
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
Comparative Efficacy of Acalabrutinib in Frontline Treatment of Chronic Lymphocytic Leukemia: A Systematic Review and Network Meta-analysis2020Clinical Therapeutics
A network meta-analysis of maintenance therapy in chronic lymphocytic leukemia2020Plos One
Risk of Bleeding Associated With Ibrutinib in Patients With B-Cell Malignancies: A Systematic Review and Meta-Analysis of Randomized Controlled Trials2020Frontiers In Pharmacology
Therapeutic options for steroid-refractory acute and chronic GVHD: an evolving landscape2020Expert Review Of Hematology
Comparison of acalabrutinib plus obinutuzumab, ibrutinib plus obinutuzumab and venetoclax plus obinutuzumab for untreated CLL: a network meta-analysis2020Leukemia & Lymphoma
Resistance-Associated Mutations in Chronic Lymphocytic Leukemia Patients Treated With Novel Agents2020Frontiers In Oncology
Ibrutinib as initial therapy in chronic lymphocytic leukemia: A systematic review and meta-analysis2020European Journal Of Haematology
Mechanisms of ibrutinib resistance in chronic lymphocytic leukemia and alternative treatment strategies2020Expert Review Of Hematology
Novel Targeted Therapies for Chronic Lymphocytic Leukemia in Elderly Patients: A Systematic Review2020Clinical Lymphoma, Myeloma & Leukemia

Clinical Practice Guidelines