FDA approves Tecartus for mantle cell lymphoma

SANTA MONICA, Calif.—Kite Pharma, a subsidiary of Gilead Sciences, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus (brexucabtagene autoleucel), reportedly the first approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

MCL is a rare form of non-Hodgkin lymphoma that arises from cells originating in the “mantle zone” of the lymph node. It predominantly affects men over the age of 60. MCL is highly aggressive following relapse, with many patients progressing after they have received therapy.

“Despite promising advances, there are still major gaps in treatment for patients with MCL who progress following initial therapy,” said Michael Wang, M.D., professor of the Department of Lymphoma and Myeloma in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, and lead investigator of ZUMA-2. “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.”

Tecartus is an autologous, anti-CD19 CAR T cell therapy. Tecartus uses the XLP manufacturing process, which includes T cell enrichment — a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature.

The approval of this one-time therapy follows a Priority Review and FDA Breakthrough Therapy designation. Approval 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 who achieved 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.

“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. 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,” added Christi Shaw, chief executive officer of Kite Pharma.

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. Kite Pharma says that training and certification on the REMS program will be an integral part of the final authorization for centers offering Tecartus.

Tecartus will be manufactured in Kite’s commercial manufacturing facility in El Segundo, California. During the ZUMA-2 trial, Kite reportedly 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 rapid progression.

“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. 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,” noted Meghan Gutierrez, chief executive officer at the Lymphoma Research Foundation. “Today’s news builds upon this progress and provides hope to mantle cell patients and their loved ones.”

Tecartus is currently under review in the European Union. The therapy has been granted Priority Medicines (PRIME) designation by the European Medicines Agency for relapsed or refractory MCL. Tecartus is also currently in Phase 1/2 trials in acute lymphoblastic leukemia and chronic lymphocytic leukemia.