Relapsed Or Refractory Large-B-Cell Lymphoma Treatment Approved
The U.S. Food and Drug Administration (FDA) announced on February 5, 2021, the approval of 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 is not indicated for treating patients with primary central nervous system lymphoma.
Breyanzi, a 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).
“Today’s approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press statement.
“Gene and cell therapies have evolved from promising concepts to practical cancer treatment regimens.”
To further evaluate the long-term safety, the FDA is requiring the manufacturer, Juno Therapeutics Inc., a Bristol-Myers Squibb Company, to conduct a post-marketing observational study involving patients treated with Breyanzi.