Kite Pharma Begins BLA for CAR-T Cell Therapy

Kite Pharma has begun a rolling BLA submission for KTE-C19 (axicabtagene ciloleucel) as a treatment for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant. The submission is supported by data from the company’s pivotal ZUMA-1 study that enrolled patients with chemorefractory diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma — three subtypes of aggressive NHL. The company expects to complete its BLA submission by the end of the first quarter of 2017. Axicabtagene ciloleucel is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells, according to the company.