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Verastem seeks FDA approval for lymphoma drug candidate

Verastem filed a new-drug application seeking full approval from the FDA for duvelisib for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, plus accelerated approval for relapsed/refractory follicular lymphoma. Verastem's filing includes data from its DUO trial, which showed duvelisib diminished the risk of disease progression or death by 48% compared with Arzerra, or ofatumumab, in patients with relapsed/refractory CLL/SLL, and the DYNAMO study, in which the drug showed an overall response rate of 41% in patients with follicular lymphoma.

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