The U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (liso-cel) for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL) in adult patients who have received two or more prior lines of therapy.
Approval was granted based on the results of an open-label, single-arm, multicenter trial dubbed TRANSCEND-MCL that found an overall response rate of 85.3% and a complete response rate of 67.6%.
Common adverse reactions among study participants included fatigue, edema, headache, cytokine release syndrome, decreased appetite, encephalopathy, and musculoskeletal pain.
“There have been few advances in the treatment of R/R MCL, and prognosis worsens for patients after each subsequent relapse, often leaving them with high disease burden and difficulty achieving deep and durable responses,” said Michael Wang, MD, lead investigator and Puddin Clarke Endowed Professor in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center in Houston. “The approval of [liso-cel] offers an important new [chimeric antigen receptor T-cell] treatment option with high rates of lasting responses and a consistent safety profile, which is critically important for these patients who currently have limited options to treat this aggressive disease.”
Sources: FDA, May 30, 2024. Bristol Myers Squibb, May 30, 2024.
