FDA Approves First CAR T-Cell Therapy, Tecartus, for Relapsed or Refractory Mantle Cell Lymphoma

The Food and Drug Administration (FDA) has granted an accelerated approval to Tecartus (brexucabtagene autoleucel, formerly KTE-X19) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL).

Tecartus, according to a press release from the manufacturer, becomes the first and only approved chimeric antigen receptor (CAR) T-cell therapy in this patient population.

“Despite promising advances, there are still major gaps in treatment for patients with MCL who progress following initial therapy,” ZUMA-2 lead investigator Dr. Michael Wang, a professor in the department of lymphoma and myeloma at The University of Texas MD Anderson Cancer Center, said in the release. “Many patients have high-risk disease and are more likely to keep progressing, even after subsequent treatments. 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% and early clinical evidence suggesting durable remissions in later lines of therapy.”

Seventy-four patients who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a Bruton tyrosine kinase inhibitor (Imbruvica or Calquence) were enrolled in the trial. Measuring objective response rate, or the proportion of patients who experienced complete or partial responses to treatment, was the main goal of the study.

The agency based its decision on data from the single-arm, open-label ZUMA-2 trial, which showed that 87% of patients responded to a single infusion of the CAR T-cell therapy. Sixty-two percent of those patients achieved a complete response after the infusion.

Among patients evaluable for safety, 18% experienced a serious or severe side effect of cytokine release syndrome (CRS) and 37% experienced serious or severe neurologic toxicities

The approval contains a boxed warning regarding the risks of neurologic toxicities and CRS associated with the use of Tecartus.

“This approval marks the first CAR T-cell therapy approved for mantle cell lymphoma patients and represents a new frontier in the treatment of this disease,” said Meghan Gutierrez, CEO of the Lymphoma Research Foundation, in the release. “In the past decade, researchers have made significant progress in our understanding of this disease and we have seen an increase in clinical trials for patients, which we hope will continue to improve treatment strategies and the options available to people with mantle cell lymphoma. Today’s news builds upon this progress and provides hope to mantle cell patients and their loved ones.”

Patients who have been prescribed Tecartus can work with Kite Konnect, a technology platform that provides patients information and assistance throughout the process of the treatment.