Posted by Michael Wonder on 01 Aug 2017
Kite files the industry's first CAR-T marketing authorisation application in Europe for axicabtagene ciloleucel
31 August 2017 - Submission based on primary analysis of ZUMA-1 in patients with aggressive NHL.
Kite Pharma today announced that it has submitted a marketing authorisation application to the EMA for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma, transformed follicular lymphoma and primary mediastinal B-cell lymphoma who are ineligible for autologous stem cell transplant.
This application represents the first chimeric antigen receptor T-cell therapy submitted to the EMA.
Axicabtagene ciloleucel is currently under review by the U.S. FDA, and the FDA has set a Prescription Drug User Fee Act action date of 29 November 2017.
