Drug updated on 12/11/2024
Dosage Form | Capsule (oral; 70 mg and 140 mg); Tablet (oral; 140 mg, 280 mg, 420 mg); Suspension (oral; 70 mg/mL) |
Drug Class | Kinase 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
Summary
- 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 Title | Year | Source |
---|---|---|
Imbruvica (ibrutinib) Prescribing Information. | 2024 | Pharmacyclics LLC, San Francisco, CA |