Bristol-Myers Squibb's (BMY.US) CAR-T therapy regulatory application was accepted by the EU.

On August 20, BMY.US announced that the European Medicines Agency (EMA) has completed the validation of its CAR-T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel) for new indications, and will begin to review the use of Breyanzi in treating adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more lines of systemic therapy. Breyanzi has been approved in Japan for the treatment of high-risk relapsed/refractory FL patients, making it the first approved CAR-T therapy for such high-risk FL patients.

Breyanzi is an autologous CAR-T cell therapy targeting CD19 antigen with defined composition and 4-1BB co-stimulatory domain. It was approved by the FDA in February 2021 for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) who have received two or more lines of systemic therapy. The unique feature of this therapy is that the proportion of CD8+ and CD4+ T cells in CAR-T therapy is controlled, which can better control the side effects of cell therapy. The 4-1BB signaling structure domain enhances the expansion and persistence of CAR-T cells.