Kite, a Gilead Company, has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The approval of this one-time therapy follows a priority review and FDA Breakthrough Therapy Designation and is based on results of ZUMA-2, a single-arm, open-label study in which 87 percent of patients responded to a single infusion of Tecartus, including 62 percent of patients achieving a complete response (CR). Among patients evaluable for safety, 18 percent experienced Grade 3 or higher cytokine release syndrome (CRS) and 37 percent experienced 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, ZUMA-2 Lead Investigator and Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “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,” said Christi Shaw, Chief Executive Officer of Kite. “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.”
Tecartus has a Boxed Warning in its product label regarding the risks of CRS and neurologic toxicities. A Risk Evaluation and Mitigation Strategy (REMS) has been approved by the FDA for Tecartus and has been combined with the Yescarta (axicabtagene ciloleucel) REMS. The REMS program will inform and educate healthcare professionals about the risks associated with Tecartus therapy, and training and certification on the REMS program will be an integral part of the final authorization for centers offering Tecartus.
MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the “mantle zone” of the lymph node and predominantly affects men over the age of 60. MCL is highly aggressive following relapse, with many patients progressing following therapy.
“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, Chief Executive Officer at the Lymphoma Research Foundation. “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.”
Tecartus will be manufactured in Kite’s commercial manufacturing facility in El Segundo, California. In the ZUMA-2 trial, Kite demonstrated a 96 percent manufacturing success rate and a median manufacturing turnaround time of 15 days from leukapheresis to product delivery. Manufacturing speed is especially critical for patients with advanced disease, who are very ill and at risk for quick progression.
KTE-X19 is currently under review in the European Union and has been granted Priority Medicines (PRIME) designation by the European Medicines Agency for relapsed or refractory MCL.