Verastem submits NDA for Develisib to FDA
Verastem announced it has submitted a New Drug Application to the U.S. FDA seeking full approval for its lead product candidate duvelisib, a first-in-class oral dual inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma, for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and accelerated approval for the treatment of relapsed or refractory follicular lymphoma. Duvelisib has received Fast Track Designation from the FDA for patients with CLL or peripheral T-cell lymphoma 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. The NDA is supported by clinical data from the randomized Phase 3 DUO study demonstrating significant efficacy, along with a consistent and manageable safety profile, of duvelisib monotherapy in patients with relapsed or refractory CLL/SLL. The DUO study met its primary endpoint with oral duvelisib monotherapy achieving a statistically significant improvement in progression-free survival compared to ofatumumab in patients with relapsed or refractory CLL/ SLL, representing a 48% reduction in the risk of disease progression or death. The NDA is also supported by results from the Phase 2 DYNAMO(TM) study in patients with indolent non-Hodgkin's lymphoma that are double-refractory to both rituximab and chemotherapy or radioimmunotherapy, which also achieved its primary endpoint with an objective response rate of 46%. In the subset of patients enrolled in DYNAMO with double-refractory FL, duvelisib demonstrated an ORR of 41%.