Idelalisib

(Zydelig®)

Idelalisib

Drug updated on 11/1/2024

Dosage FormTablet (oral; 100 mg, 150 mg)
Drug ClassKinase 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.

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Summary
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  • 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 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 BTK inhibitors (19.86%), second-generation anti-CD20 monoclonal antibodies (19.85%), and 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 chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (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 TitleYearSource
Zydelig (idelalisib) Prescribing Information.2022Gilead Sciences, Inc., Foster City, CA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines