The FDA has given full approval to brexucabtagene autoleucel (Tecartus) for adults with relapsed or refractory mantle cell lymphoma (MCL), upgrading its previous accelerated approval. This decision is based on data from the ZUMA-2 trial, including patients who had not yet received BTK inhibitors.
In this group, Tecartus showed a 91% overall response rate and a 79% complete response rate, with many patients experiencing long-lasting remissions. The median duration of response has not yet been reached, indicating deep and durable effects.
Side effects were consistent with CAR T-cell therapy but manageable, including cytokine release syndrome in 93% of patients, neurologic events in 80%, and infections in 63%. With this approval, Tecartus can now be used earlier in treatment, giving patients a better chance of long-term remission before trying other therapies.