FDA Awards Breakthrough Therapy Designation to Kite for KTE-C19

The FDA has awarded breakthrough therapy designation to Kite Pharma its KTE-C19 for treatment of patients with refractory diffuse large B cell lymphoma, primary mediastinal B cell lymphoma and transformed follicular lymphoma.

An investigational therapy, KTE-C19 consists of a patient’s genetically modified T-cells to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the surface of B cell lymphomas and leukemias.