FDA Breakthrough designation for Kite Pharma's KTE-C19

The US Food and Drug Administration has granted Breakthrough Therapy designation status to California-headquartered oncology biopharma specialist Kite Pharma’s (Nasdaq: KITE) 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).

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.

"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, chairman, president, and chief executive, adding: "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."