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Copiktra Approval History

FDA Approved: Yes (First approved September 24, 2018)
Brand name: Copiktra
Generic name: duvelisib
Dosage form: Capsules
Company: Verastem, Inc.
Treatment for: Chronic Lymphocytic Leukemia, Follicular Lymphoma

Copiktra (duvelisib) is a first-in-class, oral, dual phosphoinositide-3-kinase (PI3K)-delta/PI3K-gamma inhibitor for the treatment relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory follicular lymphoma (FL).

Development History and FDA Approval Process for Copiktra

DateArticle
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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