Priority Review for Verastem Duvelisib NDA

FDA has accepted for priority review a Verastem NDA for duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, indicated for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated review for treating relapsed or refractory follicular lymphoma. The agency has set a user fee review action target date of 10/5.

The company says PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment. The submission is based on data from late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory CLL/SLL, and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma. Both studies achieved their primary endpoints, it says.