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FDA Biologics License Application submitted for KTE-C19 for transplant ineligible relapsed/refractory patients with Non-Hodgkin Lymphoma

Apr 11, 2017

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.

  1. 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].