FDA Approves CAR T-Cell Therapy for Adults With R/R Mantle Cell Lymphoma

FDA today approved the third chimeric antigen receptor (CAR) T-cell therapy, this time granting a green light for Kite Pharma’s brexucabtagene autoleucel, the first cell-based gene therapy to treat relapsed or refractory mantle cell lymphoma (MCL).

The therapy, to be sold as Tecartus, will be used to treat adult patients with MCL who have relapsed or not responded to other treatments. This new CAR T-cell therapy will be created the same way as those already approved—brexucabtagene autoleucel will be manufactured by collecting a patient’s T cells and genetically modifying them to include a new gene that helps target and kill lymphoma cells. The engineered T cells are then infused back into the patient.

FDA officials said approval was based on a multicenter trial of 60 adults with refractory or relapsed MCL who were followed for at least 6 months after their first objective disease response. The complete remission rate after treatment was 62%, and the objective response rate was 87%.

The lead investigator of that trial, ZUMA-2, Michael Wang, MD, professor in the Department of Lymphoma and Myeloma in the Division of Cancer Medicine at The University of Texas MD Anderson Center, said that advances in MCL have nonetheless left treatment gaps for some patients after initial therapy.

“Many patients have high-risk disease and are more likely to keep progressing, even after subsequent treatments,” Wang said in a statement. “The availability of Tecartus as the first-ever cell therapy for patients with relapsed/refractory MCL provides an important option with a response rate of nearly 90 percent and early clinical evidence suggesting durable remissions in later lines of therapy.”

In December, Wang presented results from ZUMA-2 at the American Society of Hematology in Orlando, Florida.

This is the second CAR T-cell therapy approval for Kite Pharma. The company previously received approval for axicabtagene ciloleucel (Yescarta). Both therapies are subject to a Risk Evaluation and Mitigation Strategy due to the possibility of cytokine release syndrome and neurologic toxicities.

MCL is a form of non-Hodgkin lymphoma occurring in cells from the “mantle” zone of the lymph node. It is an aggressive cancer that mostly affects men over age 60.

FDA gave brexucabtagene autoleucel priority review and breakthrough therapy designations, and the treatment was handled through the accelerated approval pathway. It also received orphan drug status, with granted financial incentives to encourage drug development.