Kite Pharma submits MAA for axicabtagene ciloleucel in Europe
US-based cell therapy company Kite Pharma has filed a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel.
The MAA has been submitted for axicabtagene ciloleucel to treat patients with relapsed / refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL) who are ineligible for autologous stem cell transplant.
The current application represents the first chimeric antigen receptor (CAR) T-cell therapy that has been filed to the EMA.
Kite’s axicabtagene ciloleucel is an investigational therapy in which a patient's T-cells are engineered to express a CAR to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukaemia, and redirect the T-cells to kill cancer cells.
Kite Pharma chairman, president and chief executive officer Dr Arie Belldegrun said: “The MAA submission of axicabtagene ciloleucel marks an important global milestone in the development of engineered T-cell therapy.
“We are excited to work closely with the EMA, Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) to help bring this potentially transformative therapy to patients in the European Union (EU).”
The company’s application for marketing authorisation is based on the data from the ZUMA-1 trial that met the primary endpoint of objective response rate (ORR), with 82% of patients achieving a response after a single infusion of axicabtagene ciloleucel.
The treatment is currently under review by the US Food and Drug Administration (FDA).
Image: Micrograph of a large B-cell lymphoma. Photo: courtesy of Nephron / Wikipedia.