EMA Validates Bristol Myers Squibb's Application for Breyanzi in Treating Relapsed Follicular Lymphoma
Author: Benzinga Newsdesk | August 19, 2024 07:01am
Bristol Myers Squibb (NYSE:BMY) today announced that the European Medicines Agency (EMA) has validated its Type II variation application to expand the indication for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. Validation of the application confirms the submission is complete and allows the scientific review to begin under the EMA's centralized review procedure.
Posted In: BMY