News from the FDA/CDC

FDA grants priority review of follicular lymphoma drug


 

Duvelisib, a dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, is under priority review by the Food and Drug Administration.

The biopharmaceutical company Verastem is seeking full approval for duvelisib for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed/refractory follicular lymphoma. The FDA has set Oct. 5, 2018, as the target action date, according to Verastem.

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Duvelisib met its primary endpoint of improved progression-free survival versus ofatumumab among patients with relapsed/refractory CLL/SLL in the phase 3 DUO study, showing a 48% reduction in risk of disease progression or death. In the phase 2 DYNAMO study among patients with indolent non-Hodgkin lymphoma who are refractory to both rituximab and chemotherapy or radioimmunotherapy, duvelisib achieved an objective response rate of 46% (P less than .0001), according to Verastem.

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