The California-based biopharma firm announced this week it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the potential refractory diffuse large B-cell lymphoma treatment axicabtagene ciloleucel (previously known as KTE-C19).
The submission is the first in Europe of a chimeric antigen receptor (CAR) T-cell therapy and as such Kite is now evaluating manufacturing options in Europe, a spokesperson from the firm told Biopharma-Reporter.
Kite’s principle manufacturing facility in El Segundo, California opened in June last year with the capacity to produce volumes of the autologous therapy for up to 4,000-5,000 patients per year.
“Kite has developed a T cell engineering process for axicabtagene ciloleucel that takes an average of 17 days from receipt of the patient’s white blood cells at our manufacturing facility to release for delivery to the site for infusion of the engineered T cells back to the patient,” we were told.
“The processing of axicabtagene ciloleucel begins with the collection of the patient’s white blood cells using a standard blood bank procedure. The collected cells are then sent to our manufacturing facility in El Segundo, CA, where the peripheral blood mononuclear cells, including T cells, are isolated from the other sample components.”
The cells are then stimulated to proliferate and transduced with a retroviral vector to introduce the CAR sequence into the patient’s T cells before being propagated in cell culture bags until a sufficient number of cells are available for infusion back into the patient.
“The engineered T cells are then washed and frozen at the cell processing site, and shipped back to the clinical center where they can be administered to the patient. In preparation for administration of the engineered T cells, the patient undergoes a short chemotherapy conditioning regimen, which is intended to improve the survival and proliferative capacity of the newly infused T cells.”
The regulatory submission comes four months after Kite submitted the candidate to the US Food and Drug Administration (FDA) for review. It has an FDA action date of November 29.
Also in late March, the agency accepted to review Novartis’s CAR-T therapy CTL019 (tisagenlecleucel-T).