Drug updated on 9/4/2024
| 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
- Zydelig (idelalisib) is 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.
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- Elderly CLL Patients Study: For patients aged 80 years and older treated with targeted agents, including idelalisib, the Overall Response Rate (ORR) was 73%, and the median Progression-Free Survival (PFS) was 49.2 months.
- Maintenance Therapy in CLL: Idelalisib was mentioned among evaluated maintenance therapies, but no significant differences in Overall Survival (OS) were observed when compared to no intervention. Specific PFS outcomes for idelalisib were not provided.
- Review on Targeted Therapies in Elderly CLL Patients: Idelalisib demonstrated activity in treating CLL, showing a favorable toxicity profile and suggesting improved clinical outcomes in elderly patients.
- Pneumonitis and Severe Infections: The incidence of all-grade pneumonitis was 3.7%, with grade ≥3 pneumonitis at 3.0%. Idelalisib significantly increased the risk of pneumonitis (RR 5.53, 95% CI [2.35, 13.01], P < 0.0001). Additionally, PI3K inhibitor-based regimens, including idelalisib, had a cumulative incidence of severe infections (grade 3 or higher) at 30.89%.
- Therapy-Related Deaths in Elderly Patients: In a study of elderly CLL patients, two out of 11 documented deaths were related to therapy, including idelalisib.
- Overall assessment showed that elderly patients (≥80 years old) with CLL had an ORR of 73% and median PFS of 49.2 months when treated with targeted agents, including idelalisib, highlighting the effectiveness and feasibility of these therapies in this underrepresented subgroup. Additionally, patients with CLL/SLL on PI3K inhibitor-based regimens, including idelalisib, experienced high rates of severe infections, indicating the need for close monitoring and 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 |
|---|---|---|
| Phosphatidylinositol 3 kinase inhibitor-related pneumonitis: A systematic review and meta-analysis. | 2023 | Expert Review of Clinical Pharmacology |
| Targeted therapies in CLL/SLL and the cumulative incidence of infection: A systematic review and meta-analysis. | 2022 | Frontiers in pharmacology. |
| Pooled analysis of first-line treatment with targeted agents in patients with chronic lymphocytic leukemia aged 80 years and older | 2022 | Leukemia & lymphoma |
| Novel targeted therapies for chronic lymphocytic leukemia in elderly patients: A systematic review. | 2020 | Clinical Lymphoma, Myeloma & Leukemia |
| A network meta-analysis of maintenance therapy in chronic lymphocytic leukemia. | 2020 | PLoS One |
| 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 |