CAR-T Therapy from BMS Gains FDA Approval for Lymphoma

February 11, 2021

The FDA has approved Bristol Myers Squibb’s (BMS) CAR-T cell therapy Breyanzi for treatment of adults with relapsed or refractory large B-cell lymphoma, an aggressive form of nonHodgkin lymphoma.

The individualized cell therapy demonstrated a 73 percent overall response rate and a 54 percent complete response rate in a pivotal clinical trial that enrolled 268 patients.

Breyanzi (lisocabtagene maraleucel) will be manufactured for each individual patient at the company’s cellular immunotherapy manufacturing facility in Bothell, Wash., and will be marketed through a network of certified treatment centers as part of the Risk Evaluation and Mitigation Strategy (REMS) imposed by the FDA.

View today's stories