Drug updated on 5/17/2024
Dosage Form | Capsule (oral; 15 mg, 25 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
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Summary
- Duvelisib (Copiktra) is approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), showing favorable outcomes in these patient groups, as well as in those with iNHL, MCL, and AITL. The overall response rates vary based on disease type.
- Three systematic reviews/meta-analyses were analyzed to gather information about the safety and efficacy of Copiktra compared to other drugs used for similar conditions.
- In terms of efficacy, duvelisib demonstrates comparable results to PI3K inhibitors like idelalisib, copanlisib, and umbralisib. However, tazemetostat showed a similar objective response rate without significant differences when treating follicular lymphoma after at least two previous therapies.
- Regarding safety, duvelisib has been associated with a high incidence of adverse events including diarrhea and increased AST/ALT levels; 33% of these led to treatment discontinuation due to severe outcomes. Tazemetostat exhibited a significantly lower risk for grade ≥3 treatment-emergent adverse events compared to duvelisib and other PI3K inhibitors.
- Novel targeted therapies such as venetoclax plus rituximab combination therapy or ibrutinib monotherapy have been found to be more effective than traditional treatments like ofatumumab, particularly in terms of progression-free survival (PFS) and overall survival (OS).
- Subgroup considerations are crucial: For patients with specific genetic mutations or subtypes of lymphoma such as Mantle Cell Lymphoma (MCL) and Angioimmunoblastic T-cell lymphoma (AITL), duvelisib may offer beneficial outcomes. However, treatments like venetoclax plus rituximab might be safer options, particularly for CLL/SLL cases where multiple lines of prior therapy have been used.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Copiktra (duvelisib) Prescribing Information. | 2021 | Secura Bio, Inc., Las Vegas, NV |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Canadian evidence-based guideline for treatment of relapsed/refractory chronic lymphocytic leukemia. | 2023 | Leukemia Research |
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) T-cell lymphomas version 2.2022. | 2022 | Journal of the National Comprehensive Cancer Network |
Chronic lymphocytic leukemia/small lymphocytic lymphoma, version 4.2020. | 2020 | Journal of the National Comprehensive Cancer Network |