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FDA Accepts New Drug Application, Grants Priority Review for Duvelisib in CLL/SLL and Follicular Lymphoma

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On April 9, the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review a new drug application (NDA) for the oral agent duvelisib, a first-in-class, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. The NDA is seeking full approval for duvelisib in the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). The FDA target action date is October 5, 2018.

Duvelisib has received Fast Track designation from the FDA for patients with CLL who have received at least one prior therapy and for patients with FL who have received at least two prior therapies. In addition, duvelisib received Orphan Drug designation in the United States and the European Union for patients with CLL, SLL, and FL.

About Duvelisib

Duvelisib is a dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B cells and T cells. PI3K signaling may lead to the proliferation of malignant B cells and T cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.

Duvelisib was evaluated in late- and midstage extension trials, including DUO, a randomized, phase III monotherapy study in patients with relapsed or refractory CLL/SLL, and DYNAMO, a single-arm, phase II monotherapy study in patients with refractory indolent non-Hodgkin lymphoma. Both DUO and DYNAMO achieved their primary endpoints.

Duvelisib is also being developed for the treatment of peripheral T-cell lymphoma, which has Fast Track status.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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