Kite Pharma has submitted the first CAR-T cell therapy in Europe, seeking permission to market its axicabtagene ciloleucel (axi-cel) to treat patients with three subtypes of aggressive non-Hodgkin lymphoma (NHL).
CAR-T offers a new treatment approach in that it is specifically manufactured for each individual patient. During the process, T cells are drawn from a patient's blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient's cancer cells and other B-cells expressing a particular antigen.
Axi-cel has been developed for relapsed/refractory diffuse large B-cell lymphoma, transformed follicular lymphoma and primary mediastinal B-cell lymphoma in patients ineligible for autologous stem cell transplant.
The submission contains data from the ZUMA-1 trial, which met the primary endpoint of objective response rate of 82 percent after a single infusion of the therapy. Forty-four patients remain in ongoing response, including 39 percent in complete response at a median follow-up of 8.7 months, the firm noted.
In Europe, axi-cel has been awarded PRIME status, which is granted by the European Medicines Agency to support development and speed up review of new therapies addressing areas of high unmet need.
Consequently, EMA approval and potential launch is anticipated in 2018, Kite said.