FDA OKs Duvelisib for Some Lymphomas – APhA submits compounding comments to FDA. – (866) 348-2889.
The FDA has granted regular approval to duvelisib (COPIKTRA, Verastem) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies. The drug also received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies.
The recommended duvelisib dose is 25 mg orally twice daily, taken continuously in 28-day treatment cycles.
The CLL and SLL indication is based on a randomized, multicenter, open-label trial (NCT02004522) comparing duvelisib to ofatumumab in patients with relapsed or refractory CLL or SLL. The trial randomized patients (1:1) to either duvelisib (25 mg orally twice daily) or ofatumumab. Ofatumumab was administered intravenously at an initial dose of 300 mg, followed 1 week later by 2000 mg once weekly for 7 doses, and then 2000 mg once every 4 weeks for 4 additional doses.