Breyanzi gains EC nod for relapsed or refractory DLBCL

6 April 2022

The European Commission (EC) has granted Marketing Authorization for Bristol Myers Squibb’s (NYSE: BMY) Breyanzi (lisocabtagene maraleucel; liso-cel), a differentiated CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult

Patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy.

The Marketing Authorization, which authorizes the use of Breyanzi in all European Union (EU) member states, is based on results from the TRANSCEND NHL 001 and TRANSCEND WORLD studies evaluating the drug in adult patients with R/R DLBCL, PMBCL and FL3B, including those with a broad range of histologies and high-risk disease.

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