EU Approval Sought for Axicabtagene Ciloleucel in Non-Hodgkin Lymphoma

July 31, 2017 – Kite Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel (axi-cel) to treat 3 forms of non-Hodgkin lymphoma (NHL). Axi-cel, an anti-CD19 chimeric antigen receptor (CAR) T cell therapy, would be the first CAR T-cell therapy approved for use in Europe, according to Kite. The FDA is currently reviewing the treatment and is scheduled to make its decision on or before … (leggi tutto)