Verastem Oncology’s Copiktra (duvelisib) Receives FDA Approval for r/r 2L+ Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Shots:

• The approval is based on DUO (NCT02004522) & DYNAMO (NCT01882803) study results assessing Copiktra (25msg bid) vs ofatumumab or rituximab and to either CT or radioimmunotherapy in 319 adults in ratio (1:1) in patients with 2L+ r/r CLL/SLL or 2l+ r/r FL respectively
• DUO study results: PFS: no of events (55% vs 70%); progression disease (44% vs 62%); Death (11 vs 8); mPFS (16.4 vs 9.1 mos.); ORR (74% vs 39%); PR (74% vs 39%): DYNAMO study results: ORR 42%, CR 1%, PR 41%, patience maintaining response @ 6mos, 12 mos. (43%, 17%)
• Copiktra (duvelisib) is an PO inhibitor of phosphoinositide 3-kinase (PI3K) and a novel dual inhibitor of PI3K-delta and PI3K-gamma indicated for adult with 2L+ r/r CLL/SLL or 2l+ r/r FL 

Click here to read full press release/ article | Ref: Verastem Oncology | Image: Twitter