LAUSR

Chimeric antigen receptor T (CAR T) cell therapy has revolutionized the treatment of relapsed and refractory hematologic malignancies leading to their integration into treatment algorithms. Tisagenlecleucel received the first FDA cellular therapy approval in 2017 for pediatric and young adult acute lymphoblastic leukemia [1], quickly followed by axicabtagene ciloleucel (axi-cel) for large b-cell lymphomas [2,3]. Tisagenlecleucel soon after gained a second indication for large B-cell lymphomas [4] and most recently brexucabtage autoleucel was approved for mantle cell lymphoma in 2020 [5]. The use of CD19 targeted CAR T cells outside the clinical trial setting following FDA approval has brought to light clinical and regulatory challenges of the therapy for review.