FDA approves Breyanzi, new treatment for B-cell lymphoma

8 February 2021

The US Food and Drug Administration on Friday at last approved Breyanzi (lisocabtagene maraleucel – liso-cel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment.

Developed by US pharma major Bristol Myers Squibb (NYSE: BMY), Breyanzi, has suffered regulatory setbacks since its first filing in 2019. The drug is currently under review with the European Medicines Agency, which validated the filing in July last year.

Breyanzi is chimeric antigen receptor (CAR)-T cell therapy, is the third gene therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.

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