On Feb. 5, 2021, the FDA approved Breyanzi (lisocabtagene maraleucel), 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.

Breyanzi, a chimeric antigen receptor (CAR) T cell therapy, was 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. The FDA granted approval of Breyanzi to Juno Therapeutics, a Bristol-Myers Squibb Company.