Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 100 mg, 150 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Idelalisib (Zydelig) is associated with a cumulative incidence of severe infections (grade 3 or higher) at 30.89% in patients receiving phosphoinositide 3-kinase (PI3K) inhibitor-based regimens, which includes pneumonia (3.01 to 8.45%), febrile neutropenia (2.68 to 10.80%), and sepsis (0.9 to 4.48%). This indicates a notable safety concern compared to other therapies.
- In comparative terms, the incidence of severe infections for idelalisib is higher than that for Bruton's tyrosine kinase (BTK) inhibitors (19.86%), second-generation anti-CD20 monoclonal antibodies (19.85%), and B-cell lymphoma 2 (BCL-2) inhibitors (17.49%), highlighting the need for enhanced infection management strategies in patients treated with idelalisib.
- The studies did not provide specific efficacy outcomes for idelalisib, focusing instead on the issue of acquired resistance without delineating effectiveness among various population types or subgroups, particularly in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
- The studies focus on patients with CLL and SLL, highlighting that the cumulative incidence of severe infections in this population is influenced by the type of targeted therapy, with idelalisib associated with a 30.89% incidence of grade 3 or higher infections, underscoring the necessity for vigilant infection surveillance and effective prophylactic strategies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Zydelig (idelalisib) Prescribing Information. | 2022 | Gilead Sciences, Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Targeted therapies in CLL/SLL and the cumulative incidence of infection: A systematic review and meta-analysis | 2022 | Frontiers in Pharmacology |
Resistance-Associated Mutations in Chronic Lymphocytic Leukemia Patients Treated With Novel Agents | 2020 | Frontiers in Oncology |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Chronic lymphocytic leukemia. | 2022 | Alberta Health Services |
Chronic lymphocytic leukaemia: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2020 | Annals of Oncology |