Verastem recently announced it has submitted a new drug application (NDA) seeking full approval for duvelisib, an investigational phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma inhibitor for relapsed or refractory (r/r) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), according to a company press release.
The application also seeks accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL).
Verastem noted that duvelisib previously received FDA Fast Track Designation for the treatment of patients with CLL or peripheral T cell lymphoma (PTCL) who have received at least 1 prior treatment and for patients with FL who have received at least 2 prior treatments.
Duvelisib has also gained orphan drug designation in both the United States and the European Union for patients with CLL, SLL, and FL, according to the release.
The NDA submission was based on positive findings from the phase 3 DUO clinical trial, which showed efficacy and a manageable safety profile of duvelisib monotherapy in patients with r/r CLL/SLL, according to Verastem.
The trial met its primary endpoint with duvelisib improving progression-free survival by 48% compared with ofatumumab, according to the release.
The NDA was also supported by findings from the phase 2 DYNAMO clinical trial in patients with non-Hodgkin lymphoma whose disease was refractory to rituximab and chemotherapy or radioimmunotherapy.
The DYNAMO trial reached its primary endpoint with an objective response rate (ORR) of 46%, according to the release. A sub-analysis also showed that patients with double-refractory FL achieved an ORR of 41%.
“The submission of our first NDA for duvelisib is a major milestone for Verastem and is the culmination of substantial effort by our employees and the investigators who have dedicated themselves toward developing a potential treatment option for patients who are in need of additional therapies. We are immensely grateful to all of the patients that participated in the duvelisib clinical trial program over the last few years,” said Robert Forrester, president and chief executive officer, Verastem. “Oral duvelisib is the first PI3K inhibitor to show efficacy as a monotherapy in a randomized Phase 3 study in patients with relapsed or refractory CLL/SLL. Duvelisib monotherapy has also demonstrated significant clinical activity in patients with double-refractory FL. We believe duvelisib will offer a convenient oral treatment alternative. We look forward to working with the FDA during the review process and to a potential U.S. approval decision for duvelisib in early 2019.”