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FDA grants priority review to duvelisib for leukemia, lymphoma subtypes
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The FDA granted priority review to duvelisib for the treatment of relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma, according to the agent’s manufacturer.
The manufacturer is seeking full approval for the treatment of relapsed or refractory CLL and small lymphocytic lymphoma (SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma.
Duvelisib (Verastem) is a first-in-class oral dual inhibitor of PI3K-delta and PI3K-gamma.
“Obtaining priority review in the U.S. for duvelisib marks another important milestone for Verastem and speaks to the unmet need in relapsed/refractory CLL/SLL and follicular lymphoma and the urgency to identify effective therapies to treat these patients,” Robert Forrester, president and CEO of Verastem, said in a press release. “As an orally administered therapy, we believe duvelisib will provide an important treatment option for patients with CLL/SLL and follicular lymphoma, and for the physicians who treat them. We look forward to working with the FDA during the review process.”
The FDA assigned an action date of October 5, 2018, for this review.