Based on FDA feedback, Verastem's (VSTM +3.3%) New Drug Application (NDA) seeking approval for duvelisib will include requests for full approval for relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and accelerated approval for relapsed/refractory follicular lymphoma (FL).
The company expects to submit the NDA in Q1 2018.
Duvelisib is a dual inhibitor of two enzymes called phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. Both are associated with the growth and survival of malignant B cells and T cells.
Now read: Verastem Beats The Odds »
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