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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and timing of the post-marketing requirements were no longer merited, the FL indication for Copiktra was voluntarily withdrawn in December 2021.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

DateArticle
Dec  3, 2021Secura Bio Announces Copiktra (duvelisib) Strategic Focus On T-cell Lymphoma And Voluntary U.S. Withdrawal Of The Relapsed Or Refractory Follicular Lymphoma Indication
Sep 24, 2018Approval FDA Approves Copiktra (duvelisib) Capsules for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma
Apr  9, 2018FDA Accepts New Drug Application for Duvelisib and Grants Priority Review
Feb  7, 2018Verastem Submits NDA to FDA for Duvelisib for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma
Oct 31, 2017Verastem Announces Regulatory Strategy for Duvelisib New Drug Application Following Guidance from FDA
Sep  6, 2017Verastem Expands Duvelisib Development Program to Include Peripheral T-Cell Lymphoma

Further information

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