On 24 September 2018, the US Food and Drug Administration announced the approval of duvelisib (COPIKTRA) for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after two prior lines of therapy.
Duvelisib is the first oral dual inhibitor of phosphoinositide-3-kinase-delta (PI3K-δ) and PI3K-γ being developed by Verastem. The approval follows data from the phase III DUO trial (NCT02004522) comparing duvelisib to ofatumumab, in which the results were presented at the American Society of Hematology (ASH) in December 2017. Associate Professor Nicole Lamanna discusses the outcomes of the DUO trial in an interview with Lymphoma Hub at ASH 2017, watch here.
- 196 patients were randomized to receive either duvelisib (n = 95) or ofatumumab (n = 101).
- The estimated mean progression-free survival assessed by an independent review committee was 16.4 months for duvelisib and 9.1 months for ofatumumab (HR 0.40)
- The overall response rate was 78% for duvelisib and 39% for ofatumumab
The FDA has also accelerated the approval of duvelisib for the treatment of adult patients with R/R follicular lymphoma (FL) after two prior lines of therapy.