Posted by Michael Wonder on 09 Apr 2018
FDA accepts new drug application for duvelisib and grants priority review
9 April 2018 - Application seeks full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma and accelerated approval in relapsed/refractory follicular lymphoma.
Verastem today announced that the U.S. FDA has accepted for filing with priority review its new drug application for its lead product candidate duvelisib. Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for which Verastem is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma. The FDA target action date is 5 October 2018.
Duvelisib is a first-in-class investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signalling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumour microenvironment. Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomised, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma, and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma.
