August 10, 2017 Source: pharmatimes 174
Kite Pharma has begun treating the first EU patients with its investigational CAR–T candidate, axicabtagene ciloleucel (axi-cel), in the safety expansion cohort of the ZUMA-1 trial.
This follows a successful US trial, which met the primary endpoint of objective response rate of 82 percent after a single infusion of the therapy and led to axi-cel becomming the first CAR–T to be submitted for marketing authorisation in Europe last month.
Kite is currently enrolling adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL) at multiple EU medical centres.
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.
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.
It is also under review by the US Food and Drug Administration (FDA) for aggressive non-Hodgkin lymphoma and was granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.By Ddu
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