Posted by Michael Wonder on 20 Dec 2016
Juno Therapeutics' and Celgene Corporation's investigational drug JCAR017 granted breakthrough therapy designation from FDA and priority medicines eligibility from EMA for relapsed/refractory diffuse large B cell lymphoma
20 December 2016 - Early results recently announced with JCAR017 in non-Hodgkin lymphoma and pediatric acute lymphoblastic leukemia.
Juno Therapeutics and Celgene today announced that the U.S. FDA has granted breakthrough therapy designation to investigational drug JCAR017 for the treatment of patients with relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin's lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), not otherwise specified (de novo or transformed from indolent lymphoma), primary mediastinal B-cell lymphoma or grade 3B follicular lymphoma.
In addition, the EMA Committee for Medicinal Products for Human Use and Committee for Advanced Therapies have granted JCAR017 access to the Priority Medicines (PRIME) scheme for r/r DLBCL.
