On December 7, 2015 Kite Pharma, Inc. (Nasdaq:KITE) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to the Company’s lead product candidate, KTE-C19, for the treatment of patients with refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL) (Press release, Kite Pharma, DEC 7, 2015, View Source [SID:1234508441]). Schedule your 30 min Free 1stOncology Demo! KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.
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"The FDA’s designation of KTE-C19 as a breakthrough therapy recognizes the potential for KTE-C19 to address the unmet need for patients with refractory DLBCL, PMBCL, and TFL," noted Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "We are pleased to receive this designation and look forward to working more closely with the FDA as we continue to advance our program for KTE-C19."
Breakthrough Therapy Designation is granted by the FDA to expedite the development and review of new therapies to treat serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the therapy may have substantial improvement on at least one clinically significant endpoint over available therapy. This designation conveys all fast track program features, as well as more intensive FDA guidance on an efficient drug development program and eligibility for rolling review and priority review.