When people with relapsed or refractory mantle cell lymphoma got lisocabtagene maraleucel, the numbers were clear. Response rates hit 89 percent. Of those, 79 percent had a complete response. These results not only match but even top the pivotal TRANSCEND MCL trial, which led to the FDA approving Breyanzi for this use in May 2024.
The FDA formally approved lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory mantle cell lymphoma after at least two prior lines of therapy on May 30, 2024.
Doctors watched safety closely. Sixty-five percent of patients had cytokine release syndrome. Thirty-six percent developed immune effector cell associated neurotoxicity syndrome (ICANS). Only 14 percent had grade 3 or higher ICANS. The six month nonrelapse death rate was just 2 percent. No deaths were linked to CRS. Among the 39 percent treated as outpatients, there were no reported deaths.
Elise A. Chong, MD, assistant professor at the Hospital of the University of Pennsylvania and physician at the Abramson Cancer Center, said these real world results back up the pivotal trial data. This is the largest group reported so far for liso-cel in relapsed or refractory MCL. The safety profile stayed in line with the TRANSCEND MCL trial, with mostly low grade side effects and no new safety concerns.
In 2026, the FDA further expanded Breyanzi's indications to include relapsed or refractory marginal zone lymphoma, reflecting ongoing confidence in the platform's efficacy across multiple lymphoma subtypes.
Still, there are hurdles. Dr. Chong pointed out the need for longer-lasting treatments and better ways to sort risk, especially for people with high risk disease or those who do not respond to BTK inhibitors. The data, shared at the 2026 Society of Hematologic Oncology Annual Meeting, set a new standard for commercial CAR T cell therapy in this tough lymphoma type.
Now that real world evidence matches what was seen in trials, liso-cel's promise in relapsed or refractory mantle cell lymphoma is proven. The treatment's strong effect and manageable safety in a wider group of patients mark a clear step forward for CAR T cell therapy in blood cancers. For doctors and patients facing relapsed or refractory MCL, Breyanzi is now a proven standard. But the need for new options remains for those who still do not benefit.
Independent reporting from Medscape notes that in two real world studies presented at SOHO 2026, more than 150 patients with relapsed or refractory MCL had overall response rates of 85–89 percent and complete response rates of 75–82 percent. These results closely match those from key trials and show that liso-cel's effect holds up outside the trial setting.
