Posted by Michael Wonder on 28 May 2017
Kite receives U.S. Food and Drug Administration priority review for axicabtagene ciloleucel
26 May 2017 - Biologics license application submission based on the primary analysis of the ZUMA-1 Phase 2 trial.
Kite Pharma today announced that the U.S. FDA has accepted for priority review the biologics license Application for axicabtagene ciloleucel.
The submission follows positive data demonstrated with a single infusion of axicabtagene ciloleucel in the ZUMA-1 Phase 2 trial in patients with refractory aggressive non-Hodgkin lymphoma.
The FDA has set a Prescription Drug User Fee Act target action date of 29 November 2017.
