Oncology Drug Reference Sheet: Lisocabtagene Maraleucel

Lisocabtagene maraleucel (Breyanzi^®) was first approved by the U.S. Food and Drug Administration (FDA) in 2021 for patients with relapsed or refractory large B-cell lymphoma (LBCL), high-grade B-cell lymphoma, primary mediastinal LBCL, and grade IIIB follicular lymphoma. In 2022, the FDA expanded its approval for the initial indication to include those with refractory disease or relapse within 12 months of first-line chemoimmunotherapy who are not eligible for hematopoietic stem cell transplantation. And in 2024, the FDA gave the therapy four new indications for relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, and follicular lymphoma.