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.
Kite Pharma chairman, president, and CEO Arie Belldegrun said: "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.
"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.