Research & Development
Verastem receives new drug application from US Food and Drug Administration for duvelisib
11 April 2018 -

US-based Verastem has received US Food and Drug Administration (FDA) acceptance and been granted priority review for its new drug application for its lead product candidate, duvelisib, it was reported on Tuesday.

The product is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for which the company is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma and accelerated approval for the treatment of relapsed or refractory follicular lymphoma. The FDA target action date is 5 October 2018.

Verastem president and CEO, Robert Forrester, said: "Obtaining Priority Review in the US for duvelisib marks another important milestone for Verastem and speaks to the unmet need in relapsed/refractory CLL/SLL and FL and the urgency to identify effective therapies to treat these patients. As an orally administered therapy, we believe duvelisib will provide an important treatment option for patients with CLL/SLL and FL, and for the physicians who treat them. We look forward to working with the FDA during the review process. We are continuing our commercial preparations for duvelisib to execute the launch promptly in the U.S. if approved. In parallel, we are exploring ex-U.S. partnering opportunities for duvelisib and plan to file a European Marketing Application towards the end of the year."

Priority Review is granted by the FDA to drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition.



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