On 31 stMarch 2017, Kite Pharmacompleted its Biologics License Application (BLA) to the U.S. Food and Drug Administration ( FDA) for KTE-C19 (also known as axicabtagene ciloleucel) for transplant ineligible R/R aggressive NHL patients.
The BLA was completed subsequent to a rolling data submission, required as part of a Breakthrough Therapy Designation received in December 2015.
Results of the phase II ZUMA-1 trial ( NCT02348216) were used to base the BLA on. KTE-C19 achieved an ORR of 82% and a CR rate of 54% for R/R aggressive NHL patients. Primary results of the trial were presented at the American Association for Cancer Research (AACR) 2017 Annual meeting, reported by the Lymphoma Hub this week.