Kite Pharma files CAR-T MAA in Europe for axicabtagene ciloleucel
Kite Pharma announced that it has submitted a Marketing Authorization Application to the European Medicines Agency 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. Food and Drug Administration, and the FDA has set a Prescription Drug User Fee Act action date of November 29. The MAA for axicabtagene ciloleucel is supported by data from the ZUMA-1 trial, which met the primary endpoint of objective response rate, with 82% of patients achieving a response 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 most common Grade 3 or higher adverse events included cytokine release syndrome and neurologic events, which were generally reversible.