Kite Pharma announced that the Food and Drug Administration (FDA) has granted Priority Review of the Biologics License Application (BLA) for axicabtagene ciloleucel, an agent aimed to treat multiple non-Hodgkin lymphoma (NHL).
In December 2015, axicabtagene ciloleucel received Breakthrough Therapy Designation for diffuse large B-cell lymphoma, transformed follicular lymphoma and primary mediastinal B-cell lymphoma.
The BLA submission was based on the Phase 2 trial, ZUMA-1 where patients with refractory aggressive NHL received a single infusion of axicabtagene ciloleucal. The primary endpoint of objective response rate (ORR) was met in 82% of participants (P<0.0001). Forty-four percent of patients demonstrated ongoing response at the 8.7-month follow-up, of which 39% achieved complete response.
The single-infusion therapy resulted in adverse events such as anemia, thrombocytopenia, neutropenia, and encephalopathy, among others. In the Phase 2 trial, there were 3 deaths, two of which were deemed related to axicabtagene ciloleucel therapy.
Axicabtagen ciloleucel is an investigative T-cell therapy. Autologous T cells are modified to express a chimeric antigen receptor (CAR) which will allow cytotoxic cells to target the CD19 protein markers found on B-cell lymphoma and leukemia cells.
The Prescription Drug User Fee Act (PDUFA) target action set has been set for November 29, 2017.
For more information visit KitePharma.com.