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Duvelisib receives Orphan Drug designation from the FDA for the treatment of T-cell lymphoma

Oct 4, 2019

On the 3 rdof October 2019 the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation for duvelisib as a treatment for patients with T-cell lymphoma in addition to the previously-granted Fast Track status, for peripheral T-Cell lymphoma. 1

Duvelisib, is an oral inhibitor of phosphoinositide 3-kinase (PI3K)-δ and PI3K-γ, enzymes involved in pathways supporting the growth and survival of malignant B-cells, as well as the formation and maintenance of the tumor microenvironment.

The drug has been previously approved for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)after at least two prior therapies and accelerated approval in follicular lymphoma (FL) after at least two prior systemic therapies. The phase II PRIMO studyof duvelisib monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) is currently ongoing and will provide further data on dosing regimen, efficacy and safety.

  1. Verastem Oncology. Verastem Oncology Receives Orphan Drug Designation from FDA for COPIKTRA for the Treatment of T-Cell Lymphoma. Press release 3rd October 2019.[Accessed  October 3, 2019]