Idelalisib

(Zydelig®)

Zydelig®

Drug updated on 9/4/2024

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.

Latest News

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Summary
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  • 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.