FDA Submission Completed for Axicabtagene Ciloleucel in NHL

April 1, 2017 – A biologics license application (BLA) has been submitted for axicabtagene ciloleucel (KTE-C19) as a potential treatment for transplant ineligible patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL), according to Kite Pharma, the developer of the CAR T-cell therapy. The BLA was based on findings from the phase II ZUMA-1 study, in which axicabtagene ciloleucel demonstrated an objective response rate (ORR) of 82% and a … (leggi tutto)