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Duvelisib receives a positive opinion from the EMA CHMP for the treatment of R/R CLL and refractory FL

Mar 31, 2021
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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

  1. European Medicines Agency. Copiktra. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/copiktra. Published Mar 26, 2021. Accessed Mar 30, 2021.
  2. 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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