Kite submits MAA for CAR T therapy
Kite Pharma Inc. (NASDAQ:KITE) submitted an MAA to EMA for chimeric antigen receptor (CAR) T cell therapy axicabtagene ciloleucel (KTE-C19) to treat relapsed or refractory diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma and primary mediastinal B cell lymphoma in patients ineligible for autologous stem cell transplantation (ASCT). The company said the application is the first CAR T cell therapy submitted in Europe.
Axicabtagene ciloleucel comprises autologous T cells genetically modified to express a chimeric antigen receptor (CAR) targeting CD19. The therapy has PRIority MEdicines (PRIME) designation from EMA for DLBCL.
The product is under FDA Priority Review to treat refractory aggressive non-Hodgkin’s lymphoma (NHL) with a Nov. 29 PDUFA date (see BioCentury Extra, May 26).
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