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# FDA Priority Review for Kite’s CAR-T Cell Therapy
- URL: https://www.fdaweb.com/fda-priority-review-for-kites-car-t-cell-therapy/
- Published: 2017-05-26T12:00:00.000Z
- Updated: 2026-09-14T22:26:01.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5138793

FDA has accepted for priority review a Kite Pharma BLA for axicabtagene ciloleucel for treating non-Hodgkin lymphoma. The submission is based on data from the ZUMA-1 Phase 2 trial in patients with refractory aggressive non-Hodgkin lymphoma. The trial met the primary endpoint of objective response rate (82% achieved) recorded after a single infusion of axicabtagene ciloleucel. “At a median follow-up of 8.7 months, 44% of patients were in ongoing response, which included 39% of patients in complete response,” the company says. The agency has set a user fee review target date of 11/29.

  
Axicabtagene ciloleucel is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. It has been granted Breakthrough Therapy Designation for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.