Drug updated on 4/17/2024
| 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.
Summary
- Idelalisib (Zydelig) is indicated for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, for those who would be considered appropriate candidates for rituximab alone due to other comorbidities.
- Nine studies were analyzed regarding Zydelig's use, exploring safety concerns, effectiveness, suitable population types, and comparisons with other treatments.
- PI3K inhibitors like idelalisib have a significantly increased risk of causing pneumonitis compared to control treatments, highlighting a major safety concern that necessitates careful management.
- Targeted therapies including idelalisib are associated with considerable risks of severe infections, underscoring the need for effective prophylactic strategies and surveillance.
- Studies show that targeted agents such as idelalisib are feasible and effective in elderly patients aged 80 years or older, who often have comorbidities or high-risk disease.
- While resistance has been documented against treatments like ibrutinib and venetoclax due to specific mutations, no clear unifying resistance-associated mutations have been identified in cases of idelalisib failure, indicating its potential long-term efficacy.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zydelig (idelalisib) prescribing information. | 2022 | Gilead Sciences, Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
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 |