Juno and Celgene announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational drug JCAR017 for the treatment of relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), not otherwise specified (de novo or transformed from indolent lymphoma), primary mediastinal B-cell Lymphoma (PMBCL) or Grade 3B follicular lymphoma.

JCAR017 is a chimeric antigen T-cell receptor (CAR-T), using a defined CD4:CD8 composition and 4-1BB as the costimulatory domain, differentiating it from other CD19-directed CAR-T product candidates. 

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Data from Phase 1 studies of JCAR017 in a range of B-cell malignancies have been promising, and a trial is planned for 2017 in patients with relapsed or refractory DLBCL. 

For more information visit celgene.com.