Drug updated on 4/24/2024
| 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.
Summary
- 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 Title | Year | Source |
|---|---|---|
| Imbruvica (ibrutinib) Prescribing Information. | 2024 | Pharmacyclics LLC, Sunnyvale CA |