BioCentury
ARTICLE | Clinical News

Verastem submits NDA to FDA for duvelisib

February 9, 2018 4:14 PM UTC

Verastem Inc. (NASDAQ:VSTM) submitted an NDA to FDA for duvelisib (IPI-145) to treat relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The NDA is also seeking accelerated approval of duvelisib to treat relapsed or refractory follicular lymphoma (FL).

Duvelisib met the primary endpoint of improving progression free survival (PFS) vs. Arzerra ofatumumab in the Phase III DUO trial to treat relapsed or refractory CLL and SLL and the primary endpoint of objective response rate (ORR) in the Phase II DYNAMO trial, which included FL patients (see BioCentury, Sept. 8, 2017 & Dec. 15, 2017). The candidate missed the secondary endpoint of improving overall survival (OS) in DUO...