Posted by Michael Wonder on 21 Dec 2022
CAR T cell therapy Breyanzi approved as relapsed or refractory large B-cell lymphoma second-line therapy in Japan
20 December 2022 - Bristol-Myers Squibb today announced that it has received approval in Japan for Breyanzi (lisocabtagene maraleucel), a CD19 targeting chimeric antigen receptor (CAR) T cell therapy, allowing its use in the second-line treatment of relapsed or refractory large B-cell lymphoma, regardless of whether autologous haematopoietic stem cell transplantation is intended.
This approval is based on the results of clinical trials in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma after first-line therapy, including global Phase 3 clinical trials (JCAR017-BCM-003) in patients intended for autologous haematopoietic stem cell transplantation, Phase 2 clinical trials (017006) in the US in patients not intended for autologous haematopoietic stem cell transplantation, and cohort 2 of Phase 2 clinical trials (JCAR017-BCM-001) in Europe and Japan.
