The US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for lisocabtagene maraleucel (liso-cel; Breyanzi) for adults with relapsed or refractory marginal zone lymphoma (MZL) after two or more prior therapies.
The FDA has granted Priority Review to the application and assigned a Prescription Drug User Fee Act goal date of December 5, 2025, according to a press release from Bristol Meyers Squibb, the manufacturer of the therapy.
“This FDA acceptance brings us one step closer to potentially standardizing CAR T cell therapy as a treatment option for MZL, while building on our commitment to bring this personalized therapy to as many eligible patients as possible,” said Rosanna Ricafort, the Global Program Lead for Hematology and Cell Therapy at BMS, in the company release.
