Regulation

The US FDA accepts for priority review Bristol-Myers Squibb’s BLA for liso-cel for adult patients with relapsed or refractory large B-cell lymphoma

Bristol-Myers Squibb (BMS) announced that the US Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.