Juno Therapeutics, Celgene Get Breakthrough Therapy Designation From FDA

(RTTNews) - Juno Therapeutics, Inc. (JUNO) and Celgene Corp. (CELG) Tuesday announced that the Food and Drug Administration has granted Breakthrough Therapy designation to investigational drug JCAR017 for the treatment of patients with relapsed/refractory aggressive large B-cell non-Hodgkin lymphoma. This will include diffuse large B-cell lymphoma, not otherwise specified, Primary Mediastinal B-cell Lymphoma or Grade 3B Follicular Lymphoma.

The companies noted that the European Medicines Agency Committee for Medicinal Products for Human Use and Committee for Advanced Therapies have granted JCAR017 access to the Priority Medicines scheme for relapsed/refractory diffuse large B-cell lymphoma or DLBCL.

Mark Gilbert, Juno's Chief Medical Officer said, "The Breakthrough Therapy designation from the FDA and PRIME eligibility from EMA for JCAR017 highlight the need for new treatment options for patients with DLBCL, particularly for the significant number of patients who do not respond to initial therapy or with relapsed disease."