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The Food and Drug Administration (FDA) has approved Copiktra (duvelisib; Verastem Oncology) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies; and for relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies. The FL indication was approved under an accelerated approval pathway based on overall response rate; continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, which are 2 enzymes involved in the growth and survival of malignant B- and T-cells. In a clinical trial involving patients with CLL (N=312) or SLL (N=7), median progression-free survival (PFS) was 16.4 months for patients treated with duvelisib vs 9.1 months for those treated with ofatumumab; overall response rate (ORR) was also greater in duvelisib-treated patients compared with the ofatumumab group (74% vs 39%, respectively). In a single-arm trial of patients with previously treated FL (N=83) who received duvelisib, ORR was found to be 42%, with 43% of patients maintaining response at 6 months and 17% of patients maintaining response at 12 months.
Copiktra carries a Boxed Warning regarding the risk of fatal and serious infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. The most common adverse reactions associated with therapy include diarrhea, colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain and anemia. In order to provide appropriate dosing and safety information to clinicians, Verastem Oncology will be implementing an informational Risk Evaluation and Mitigation Strategy (REMS) for Copiktra.
Copiktra is available in 15mg and 25mg capsules and is supplied in cartons containing 2 x 28-count blister packs and 56-count bottles.
For more information call (833) 570-2273 or visit Verastem.com.
