Copiktra FDA Approval History
Last updated by Judith Stewart, BPharm on May 18, 2022.
FDA Approved: Yes (First approved September 24, 2018)
Brand name: Copiktra
Generic name: duvelisib
Dosage form: Capsules
Company: Secura Bio, Inc.
Treatment for: Chronic Lymphocytic Leukemia
Copiktra (duvelisib) is a first-in-class, oral, dual phosphoinositide-3-kinase (PI3K)-delta/PI3K-gamma inhibitor for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Copiktra has been approved 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.
- Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.
The FL indication was approved under accelerated approval based on overall response rate in September 2018. Continued approval for the FL indication was contingent upon verification and description of clinical benefit in confirmatory trials. After a strategic business assessment determined the logistics, cost and timing of the post-marketing requirements were no longer merited, the FL indication for Copiktra was voluntarily withdrawn in December 2021.
Development timeline for Copiktra
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