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The approval comes after positive results were met in a single-arm, open-label study that resulted in FDA Breakthrough Therapy Designation for the one-time therapy.
Kite, a Gilead Company, announced on July 24, 2020 that FDA granted accelerated approval to Tecartus (brexucabtagene autoleucel), a chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
According to a company press release, the approval comes after positive results were met in a single-arm, open-label study which resulted in FDA Breakthrough Therapy Designation for the one-time therapy. In the study, 87% of patients responded to a single infusion of Tecartus, with 62% of patients achieving a complete response, 18 % experiencing a grade 3 or higher cytokine release syndrome, and 37% experiencing grade 3 or higher neurologic toxicities.
“Despite promising advances, there are still major gaps in treatment for patients with MCL who progress following initial therapy,” said Michael Wang, MD, lead investigator and professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, in the press 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 percent and early clinical evidence suggesting durable remissions in later lines of therapy.”
“Kite is committed to bringing the promise of CAR-T therapy to patients with hematological cancers, and as such, we are proud to launch our second cell therapy,” added Christi Shaw, CEO of Kite, in the press release. “I extend my thanks to the patient study participants, caregivers, clinical researchers, regulators, and dedicated colleagues at Kite who helped make this approval possible, and we look forward to partnering with the lymphoma community to deliver this potentially transformative therapy to patients with relapsed or refractory MCL.”