Priority Review Granted for Axicabtagene Ciloleucal in NHL
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.