Drug updated on 9/4/2024
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 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.
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Summary
- Imbruvica (ibrutinib) is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion, for the treatment of adult patients with Waldenström’s macroglobulinemia (WM), and for the treatment of adult and pediatric patients aged 1 year and older with chronic graft versus host disease (cGVHD) after the failure of one or more lines of systemic therapy.
- This summary is based on the review of 15 systematic review(s)/meta-analysis(es). [1-17]
- Bendamustine Rituximab (BR) demonstrated a pooled response rate of 46% with a two-year progression-free survival (PFS) of 89%. Bortezomib-Dexamethasone, Cyclophosphamide, Rituximab (BDRC) had a pooled response rate of 33% and a two-year PFS of 81%. Ibrutinib Rituximab (IR) showed a pooled response rate of 26% and a two-year PFS of 82%.
- The overall response rate (ORR) for chronic graft-versus-host disease (cGVHD) was 54-78% in pediatric patients and 67-76% in adult patients.
- In chronic lymphocytic leukemia (CLL), first-line treatment in real-world settings yielded a 12-month overall survival (OS) of 95-96% and an 18-month OS of 91%. The 12-month progression-free survival (PFS) ranged from 89-93%, with an overall response rate of 71-90%. Obinutuzumab + Acalabrutinib was most effective in network meta-analyses, while Ibrutinib and Venetoclax + Rituximab showed superior PFS and OS in meta-analyses.
- Common adverse effects observed included pyrexia, diarrhea, abdominal pain, cough, nausea, stomatitis, vomiting, headache, bleeding, bruising, infection, muscle aches, and fatigue.
- Specific safety concerns in Chronic Lymphocytic Leukemia (CLL) included an increased risk of bleeding (overall and major) and higher risk of infections (any grade and grade 3-5) in B-cell malignancies, with abdominal manifestations notably higher in patients treated with ibrutinib.
- Infection rates associated with different therapies were as follows: BTK inhibitors (19.86%), PI3K inhibitors (30.89%), and BCL-2 inhibitors (17.49%).
- Pediatric and adult populations with cGVHD showed similar but slightly different overall response rates (54-78% in pediatric, 67-76% in adults). In CLL, high-risk genomic features (del[17p], del[11q], unmutated IGHV) were included in real-world studies, showing consistent effectiveness and safety profiles. In WM, patients with CXCR4 mutations exhibited specific clinical characteristics, including lower response rates and progression-free survival to BTK inhibitors, notably ibrutinib.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Imbruvica (ibrutinib) Prescribing Information. | 2024 | Pharmacyclics LLC, Sunnyvale CA |