FDA gives priority review for IPI 145 in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.- Verastem.

Verastem announced that the FDA has accepted for filing with Priority Review its New Drug Application (NDA) for its lead product candidate IPI 145 (duvelisib). Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for which Verastem is seeking full approval for 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 was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase III monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and DYNAMO, a single-arm, Phase II monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL). Both DUO and DYNAMO achieved their primary endpoints and the FDA is reviewing a New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL).