FDA Approval Sought for Duvelisib in CLL, Follicular Lymphoma

February 7, 2018 – A new drug application (NDA) has been submitted to the FDA for duvelisib for a full approval for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma. The NDA includes supporting data from the phase III DUO trial and the phase II DYNAMO study. In DUO, duvelisib reduced the … (leggi tutto)