Bristol Myers' (BMY) Breyanzi Label Expansion Application Validated

Bristol Myers Squibb (BMY) announced that the European Medicines Agency (“EMA”) has validated its type II variation application to expand the indication for CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel).The application seeks to expand Breyanzi’s label 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 th ...