Dr. Flinn on the FDA Approval of Duvelisib in CLL and Follicular Lymphoma

Ian Flinn, MD
Published: Monday, Sep 24, 2018



Ian Flinn, MD, director of the Blood Cancer Research Program, Sarah Cannon Research Institute, discusses the FDA approval of duvelisib (Copiktra) for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or relapsed/refractory follicular lymphoma.

Findings from the phase III DUO trial and the phase II DYNAMO study supported this approval. In the DUO study, duvelisib reduced the risk of disease progression or death by 60% versus ofatumumab (Arzerra) in patients with relapsed/refractory CLL/SLL who had received at least 2 prior lines of therapy. In the DYNAMO study, duvelisib demonstrated an overall response rate of 42% in patients with follicular lymphoma.

The CLL/SLL indication is a standard approval and the follicular lymphoma indication is an accelerated approval contingent on the results of a confirmatory trial. Patients with either CLL, SLL, or follicular lymphoma must have undergone at least 2 prior therapies.
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Ian Flinn, MD, director of the Blood Cancer Research Program, Sarah Cannon Research Institute, discusses the FDA approval of duvelisib (Copiktra) for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or relapsed/refractory follicular lymphoma.

Findings from the phase III DUO trial and the phase II DYNAMO study supported this approval. In the DUO study, duvelisib reduced the risk of disease progression or death by 60% versus ofatumumab (Arzerra) in patients with relapsed/refractory CLL/SLL who had received at least 2 prior lines of therapy. In the DYNAMO study, duvelisib demonstrated an overall response rate of 42% in patients with follicular lymphoma.

The CLL/SLL indication is a standard approval and the follicular lymphoma indication is an accelerated approval contingent on the results of a confirmatory trial. Patients with either CLL, SLL, or follicular lymphoma must have undergone at least 2 prior therapies.



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