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New drug application for duvelisib accepted and granted priority review by FDA
By Sara Valente
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It was announced in a press release that the US Food and Drug Administration has accepted a new drug application for duvelisib and granted a priority review on 09 April 2018.
Duvelisib is the first oral dual inhibitor of phosphoinositide-3-kinase-delta (PI3K-δ) and PI3K-γ being developed by Verastem. The company hopes to see full approval of duvelisib for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and accelerated approval for the treatment of R/R follicular lymphoma.
Robert Forrester, President and Chief Executive Officer of Verastem commented that the priority review, "speaks to the unmet need in relapsed and refractory CLL and FL and the urgency to identify effective therapies to treat these patients". The FDA target action date has been established as 05 October 2018.
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