February 8, 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.
Duvelisib is a PI3K delta and -gamma inhibitor and has shown efficacy as monotherapy in a randomized phase III study in patients with relapsed or refractory CLL/SLL. Duvelisib monotherapy has also demonstrated significant clinical activity in patients with double-refractory follicular lymphoma.
The NDA includes supporting data from the phase III DUO trial where duvelisib reduced the risk of disease progression or death by 48% versus ofatumumab (Arzerra) in patients with relapsed/refractory CLL/SLL. In the overall population, the median progression-free survival (PFS) was 3.4 months longer with duvelisib compared to ofatumumab. In patients with a 17p deletion (del[17p]), the median PFS benefit was 3.7 months.
In the DYNAMO study, duvelisib demonstrated an overall response rate (ORR) of 46% (P <.0001) for patients with indolent non-Hodgkin lymphoma (iNHL), including 41% in patients with follicular lymphoma.
The most common grade ≥3 AEs were neutropenia (23%), anemia (12%), thrombocytopenia (10%), and diarrhea (15%). Seventeen percent of patients discontinued duvelisib due to an AE. There were 6 patient deaths related to AEs.
A decision is expected from the FDA in early 2019