We are currently developing duvelisib, a dual inhibitor of phosphoinositide 3-kinase (PI3K-delta and PI3K-gamma), which has successfully met its primary endpoint in a Phase 3 registration trial in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and a Phase 2 study in refractory indolent (slow-growing) non-Hodgkin’s lymphoma (iNHL).

We have a COM (composition-of-matter) patent protection of duvelisib through 2030 before extensions, and has received orphan drug designation for duvelisib in follicular lymphoma (FL), CLL and small lymphocytic lymphoma (SLL) in the United States and the European Union. The U.S. Food and Drug Administration (FDA) has granted fast track designation to the investigation of duvelisib for the potential treatment of patients with CLL who have received at least one prior therapy, of patients with FL who have received at least two prior therapies and of patients with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy.

In April 2018, the FDA accepted with Priority Review our New Drug Application (NDA) for duvelisib.