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WASHINGTON -- The FDA on Friday approved the first chimeric antigen receptor (CAR) T-cell therapy for relapsed or refractory mantle cell lymphoma (MCL).

Brexucabtagene autoleucel (Tecartus) consists of a patient's own T cells, which are genetically modified to target and kill MCL cells and then infused back into the patient. Existing CAR T-cell therapies, axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), are produced in a similar manner but target a type of acute lymphoblastic leukemia and certain aggressive B-cell lymphomas, respectively.

"This approval is yet another example of customized treatments that use a patient's own immune system to help fight cancer, while using a scientific advance in this promising new area of medicine," Peter Marks, MD, PhD, of the FDA Center for Biologics Evaluation and Research, said . "We're seeing continued advances in the field of gene therapy and remain committed to supporting innovation in this promising new area of medicine."

The therapy will help fill a major treatment gap for patients with MCL, who often progress following initial therapy, Michael Wang, MD, of the University of Texas MD Anderson Cancer Center, said in a , whose subsidiary, Kite, developed the product.

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

ZUMA-2 involved 74 adults with relapsed/refractory MCL, including 60 patients followed for at least 6 months after a first objective response. Treatment with brexucabtagene autoleucel resulted in an objective response rate of 87%, including complete responses in 62% of patients. All of the patients had previously received standard chemotherapy, an anti-CD20 antibody, and a Bruton tyrosine kinase inhibitor.

Analysis of data from the safety cohort (n=82) showed that 18% of patients developed grade ≥3 cytokine release syndrome (CRS), and 37% developed neurologic events, recognized toxicities associated with CAR T-cell therapy. Brexucabtagene autoleucel packaging will include a boxed warning about the risk of CRS and neurologic toxicity. Use of the product will be subject to an FDA-approved risk mitigation program that Gilead/Kite developed for axicabtagene ciloleucel.

Other grade ≥3 adverse events that occurred in at least 10% of patients were anemia, neutropenia, thrombocytopenia, hypotension, hypophosphatemia, encephalopathy, leukopenia, hypoxia, pyrexia, hyponatremia, hypertension, infections, pneumonia, hypocalcemia, and lymphopenia.

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