The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s Breyanzi (Lisocabtagene maraleucel) as a treatment for adults with marginal zone lymphoma (MZL) who have not responded to or have relapsed after two or more previous treatments. This is the fifth cancer type for which Breyanzi has been approved in the US, making it the most widely approved CD19-directed CAR T cell therapy. Lynelle Hoch, President of the Cell Therapy Organization at Bristol Myers Squibb, stated that this approval further establishes Breyanzi as the leading CAR T cell therapy for a broad range of B-cell malignancies. The approval is based on results from the TRANSCEND FL trial, where 95.5% of patients responded to a single infusion of Breyanzi, with 62.1% experiencing a complete response. Dr. Vijay Kumar, Acting Director of the Office of Therapeutic Products at the FDA, noted the high and durable response rate following a one-time treatment. Dr. Lia Palomba, an investigator in the TRANSCEND FL study, highlighted the need for new treatment options with durable outcomes for patients who experience multiple relapses. Dr. Vinay Prasad, Chief Medical and Scientific Officer at the FDA, described the approval as a major advancement in precision medicine, using the patient’s immune system to treat MZL more effectively. Breyanzi is also authorized to treat four other cancer types: large B-cell lymphoma, small lymphocytic lymphoma, follicular lymphoma, and mantle cell lymphoma. In the EU, the European Commission authorized the CAR T therapy for lymphoma in 2023.