A New Immunotherapeutic for Patients With Lymphoma

The FDA approved a CAR T-cell therapy – a class of cancer immunotherapy – to treat certain patients with large B-cell lymphoma, the most common form of non-Hodgkin lymphoma.

The U.S. Food and Drug Administration (FDA) has approved lisocabtagene maraleucel (Breyanzi) to treat certain adult patients with various types of B-cell lymphomas, which are cancers that originate in B cells, a type of white blood cells, in the immune system. 

The approval for lisocabtagene maraleucel is for adult patients who have received previous treatments for relapsed or refractory large B-cell lymphoma as well as patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

Lisocabtagene maraleucel is a form of adoptive cell therapy in which doctors extract T cells from a patient’s blood, genetically modify the cells in the lab, and then reintroduce the modified cells back into the patient’s body to seek out and destroy the cancer cells. 

The data to demonstrate efficacy was collected in a single-arm, open label, multicenter trial that enrolled patients with relapsed or refractory large B-cell lymphoma who had received previous treatments. Of the 192 patients who were evaluable for response, the overall response rate was 73 percent, with a complete response rate of 54 percent. Of the 104 patients who achieved a complete response, 65 percent had remissions lasting at least six months and 62 percent had remissions lasting at least nine months. 

The adverse inflammatory response known as cytokine release syndrome occurred in 46 percent of patients in the study and neurologic toxicity occurred in 35 percent, with three patients developing fatal neurologic toxicity. Due to the possibility of such life-threatening reactions, the FDA approved lisocabtagene maraleucel with a Risk Evaluation and Mitigation Strategy. This labeling helps to ensure that the benefits of the medication outweigh its risks, and it helps the physicians with preventing, monitoring, and/or managing the toxic reactions. 

B-cell lymphomas comprise about 85 percent of all the non-Hodgkin lymphoma cases in the United States. The most common type is DLBCL, a fast-growing cancer that usually affects older individuals and starts in the lymph nodes or other organs. Primary mediastinal large B-cell lymphoma, another subtype, often occurs in younger patients and begins in the chest. 

The FDA rendered its approval on February 5, 2021.