The U.S. Food and Drug Administration (FDA) granted lisocabtagene maraleucel (liso-cel) accelerated approval for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) in adult patients who received at least two prior lines of therapy. The treatment is a CD-19 directed chimeric antigen receptor (CAR) T-cell therapy.
Approval was granted based on the results of an open-label, global, multicenter, phase II trial dubbed TRANSCEND FL, which found an overall response rate of 95.7% and a complete response rate of 73.4%.
Common adverse reactions included cytokine release syndrome, headache, constipation, fatigue, fever, and musculoskeletal pain.
“In the treatment of R/R FL, patients often cycle through treatments with typically shorter responses with each new line of therapy. Those who have experienced early disease progression have notably poor prognosis,” said M. Lia Palomba, MD, TRANSCEND investigator and lymphoma and cell therapy specialist at Memorial Sloan Kettering Cancer Center in New York. “The FDA approval of liso-cel for patients with R/R FL is an important advancement in addressing an ongoing unmet need in the FL treatment paradigm, providing patients a new option that has shown remarkably high response rates and an established safety profile.”
Sources: FDA, May 15, 2024. Business Wire, May 15, 2024.
