Implementing chimeric antigen receptor T-cell therapy in practice

摘要

Advanced therapy medicinal prod ucts (ATMPs) are innovative products based on cells or tissues. They comprise gene therapies, somatic cell therapies and tissue engineered products. Chimeric antigen receptor T-cells (CART cells) are classed as gene therapies. In August 2018, two CART cell products - tisagenlecleucel and axicabtagene ciloleucel - were granted marketing authorisations by the European Medicines Agency for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic chemotherapy in adults. Tisagenlecleucel was also approved for use in the EU in 2018 for refractory B-cell acute lymphoblastic leukaemia (ALL) in patients up to the age of 25 years.