Breakthrough Designation Granted for Lymphoma Drug
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.
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.