On 31st March 2017, Kite Pharma completed 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.
- FDA Submission Completed for Axicabtagene Ciloleucel in NHL. 2017 Apr 01. http://www.onclive.com/web-exclusives/fda-submission-completed-for-axicabtagene-ciloleucel-in-nhl. [Accessed 2017 Apr 11].