Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental biologics license application (sBLA) for Breyanzi® (lisocabtagene maraleucel) under Priority Review. This application aims to expand the use of Breyanzi as a treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. If approved, Breyanzi would become the first and only CAR T cell therapy available for MZL, addressing a high unmet medical need. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 5, 2025, for the review completion. This milestone reflects BMS's ongoing efforts to enhance access to innovative cell therapies for cancer patients.
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