Kite first to submit CAR-T therapy in Europe

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.