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FDA Approves Duvelisib for Adult Patients With Relapsed or Refractory Hematologic Malignancies


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ON SEPTEMBER 24, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to duvelisib (Copiktra) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Duvelisib also received accelerated approval for adults with relapsed or refractory follicular lymphoma after at least two prior systemic therapies.

DUO Trial

THE CLL and SLL indication is based on the randomized, multicenter, open-label DUO trial, which compared duvelisib with ofatumumab (Arzerra) in patients with relapsed or refractory CLL or SLL (National Cancer Institute [NCI] ClinicalTrials.gov identifier NCT02004522). The trial randomized patients (1:1) to receive either duvelisib at 25 mg orally twice daily (the recommended dose) or ofatumumab. Ofatumumab was administered intravenously at an initial dose of 300 mg, followed 1 week later by 2,000 mg once weekly for 7 doses and then 2,000 mg once every 4 weeks, for 4 additional doses.

Among 196 patients receiving at least 2 prior therapies, the estimated median progression-free survival as assessed by an independent review committee was 16.4 months with duvelisib and 9.1 months with ofatumumab. The overall response rate per independent review committee was 78% and 39% for the duvelisib and ofatumumab arms, respectively.

DYNAMO + R Trial

THE FOLLICULAR lymphoma indication is based on the single-arm multicenter DYNAMO + R trial of duvelisib, which enrolled 83 patients with follicular lymphoma whose disease was refractory to rituximab (Rituxan) and either chemotherapy or radioimmunotherapy (NCI ClinicalTrials.gov identifier NCT02204982). The overall response rate, determined by an independent review committee, was 42%, with 41% of patients experiencing partial responses. Of the 35 responding patients, 15 (43%) maintained responses for at least 6 months, and 6 (17%) maintained responses for at least 12 months.

The prescribing information contains boxed warnings for fatal and/or serious infections, diarrhea or colitis, cutaneous reactions, and pneumonitis as well as warnings for neutropenia and hepatotoxicity.

Of 442 patients treated with duvelisib at the approved dose, 65% had serious adverse reactions. The most common adverse reactions were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. ■


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