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Duvelisib receives a positive opinion from the EMA CHMP for the treatment of R/R CLL and refractory FL
By Sumayya Khan
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On March 25, 2021, it was announced that duvelisib received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and refractory follicular lymphoma (FL).1
Duvelisib is a dual inhibitor of PI3K-δ and PI3K-γ; therefore, it blocks the proliferation and survival of malignant B-cell lines and primary CLL tumor cells, as well as immunological pathways in the tumor microenvironment of malignant B cells.1
Duvelisib has already been granted approval by the U.S. Food and Drug Administration (FDA) for patients with R/R FL and patients with R/R CLL or small lymphocytic lymphoma, which was based on the DYNAMO (NCT01882803) and DUO (NCT02004522) trial results.2
- European Medicines Agency. Copiktra. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/copiktra. Published Mar 26, 2021. Accessed Mar 30, 2021.
- U.S. Food and Drug Administration. duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). https://www.fda.gov/drugs/resources-information-approved-drugs/duvelisib-copiktra-verastem-inc-adult-patients-relapsed-or-refractory-chronic-lymphocytic-leukemia. Published Sep 24, 2018. Accessed Mar 30, 2021.
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