FDA Approves Duvelisib for Patients with CLL or SLL

The U.S. Food and Drug Administration has approved the PI3K inhibitor duvelisib for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior therapies.

The agency’s decision is based on results from the randomized, multicenter, open-label DUO trial, in which patients were treated with either duvelisib or ofatumumab. Compared with ofatumumab, treatment with duvelisib was associated with longer median progression-free survival (16.4 months vs. 9.1 months; p value not provided) and a higher overall response rate (ORR; 78% vs. 39%; p value not provided).

The drug also received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) who have received two prior systemic therapies, based on results from the single-arm multicenter DYNAMO trial. Among patients with FL that was refractory to rituximab and either chemotherapy or radioimmunotherapy, duvelisib was associated with an ORR of 42 percent.

Sixty-five percent of patients treated with duvelisib experienced serious adverse events (AEs), most frequently infection, diarrhea or colitis, and pneumonia. The most common AEs were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

Source: FDA press release, September 24, 2018; Business Wire, September 24, 2018.