Bristol Myers says FDA accepts sBLA for Breyanzi

Bristol Myers (BMY) Squibb announced that the U.S. Food and Drug Administration has accepted the supplemental biologics license application for Breyanzi as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act goal date of December 5, 2025. “While initial therapy for MZL can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates,” said Rosanna Ricafort, vice president, Senior Global Program Lead for Hematology and Cell Therapy, Bristol Myers Squibb. “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.”