Product Profile

Duvelisib is a potent and selective oral small molecule inhibitor of PI3K-δ (delta) and PI3K-γ (gamma). Verastem has COM (composition-of-matter) patent protection of duvelisib through 2030 before extensions, and has received orphan drug designation for duvelisib in follicular lymphoma (FL), chronic lymphocytic leukemia (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.

Clinical Development of Duvelisib

The only dual inhibitor of PI3K-δ,γ with positive Phase 3 results, duvelisib has the potential to be a first-in-class treatment for certain types of hematologic malignancies.

Verastem provided the clinical data below to the U.S. Food and Drug Administration (FDA) in a New Drug Application (NDA), which the FDA accepted with Priority Review in April 2018.