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Duvelisib new drug application submitted to FDA for R/R CLL and relapsed FL

Feb 8, 2018

It was announced in a press release on 7 February 2018 that Verastem has submitted a New Drug Application to the US food and drug administration (FDA) for the use of duvelisib in the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and an accelerated approval for relapsed follicular lymphoma (FL).

Duvelisib is the first oral dual inhibitor of phosphoinositide-3-kinase-delta (PI3K-δ) and PI3K-γ that has been showing potential in the treatment of R/R CLL, indolent non-Hodgkin lymphomas (iNHL) and T-cell lymphomas. In 2016, a review article highlighted duvelisib as a new drug in FL with encouraging results in refractory patients.

At the 59th meeting of the American Society of Hematology (ASH) in Atlanta, December 2017, results from the phase III DUOTM trial presented that duvelisib met its primary endpoint as showing significantly longer progression-free survival (PFS) compared with ofatumumab. In an interview with Lymphoma Hub, associate professor Nicole Lamanna from the Columbia University Medical Center in New York, provided insight into this trial. She told the hub, “we expected maybe a little bit longer progression free survival,” however, it is definitely useful to have other agents in the armamentarium, “especially if they have less toxicity.” She added, “duvelisib may represent one additional drug that you can consider for your relapsed, refractory patients with chronic lymphocytic leukemia.”