The U.S. Food and Drug Administration has granted approval to lisocabtagenemaraleucel, for the treatment of adult patients with some forms of large B-cell lymphoma who either do not respond to, or have relapsed, following at least two systemic treatments with other agents.

This drug is a chimeric antigen receptor (CAR) T cell therapy. This has become the third gene therapy to be granted FDA approval for the treatment of some types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). However, the therapy is not indicated for patients with primary central nervous system lymphoma.

A multicenter clinical trial of over 250 adult patients with refractory or relapsed large B-cell lymphoma determined the safety and efficacy of this therapy. There was a 54% complete remission rate following treatment with lisocabtagenemaraleucel… (FDA, February 5, 2021)