On October 18, 2017, the FDA approved the ex vivo gene therapy product axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.30,31

Axicabtagene ciloleucel is a chimeric antigen receptor (CAR) T-cell immunotherapy.30 It consists of autologous T cells that are genetically modified ex vivo by retroviral transduction to produce a CAR protein, allowing the T cells to identify and eliminate CD19-expressing normal and malignant cells.30,31