Posted by Michael Wonder on 04 Aug 2025
Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) accepted for priority review by US FDA in fifth cancer type for relapsed or refractory marginal zone lymphoma
4 August 2025 - Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application for Breyanzi (lisocabtagene maraleucel; liso-cel) 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 PDUFA goal date of 5 December 2025.
