Verastem announced that the Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for duvelisib for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and relapsed or refractory follicular lymphoma (FL). Specifically, the Company is seeking full approval for the treatment of patients with relapsed or refractory CLL/SLL as well as accelerated approval for relapsed or refractory FL.
Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, which are 2 enzymes involved in the growth and survival of malignant B- and T-cells. The investigational agent was evaluated in the Phase 3, randomized, DUO monotherapy study (N=319) in patients with CLL/SLL, as well as the Phase 2, single-arm DYNAMO monotherapy study (N=129) in patients with refractory indolent non-Hodgkin lymphoma (iNHL). Both studies met their primary endpoints.
Duvelisib is also being studied for the treatment of peripheral T-cell lymphoma (PTCL) in the Phase 2, multicenter, parallel-group, open-label PRIMO trial, for which it has received Fast Track status.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of October 5, 2018.
For more information call (781) 292-4200 or visit Verastem.com.