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news.Gilead company Kite has secured accelerated approval from the US Food and Drug Administration (FDA) for its Tecartus (brexucabtagene autoleucel) to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL).
The US FDA’s Centre for Drug Evaluation and Research. (Credit: The U.S. Food and Drug Administration)
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Tecartus, earlier known as KTE-X19, is claimed to be the first and only approved chimeric antigen receptor (CAR) T cell therapy to treat relapsed or refractory MCL.
Tecartus, an autologous and anti-CD19 CAR T cell therapy, uses the XLP manufacturing process that is comprised of T cell enrichment, a crucial step in certain B-cell malignancies in which circulating lymphoblasts are a common feature.
MCL is a rare form of non-Hodgkin lymphoma (NHL), which emerges from cells originating in the mantle zone of the lymph node and predominantly affects men more than the age of 60.
The approval, which follows a priority review and FDA breakthrough therapy designation, is based on data from the single-arm and open-label ZUMA-2 study in which 87% of patients responded to a single infusion of Tecartus, including 62% of patients achieving a complete response (CR), said the company.
The ZUMA-2 trial recruited 74 adult patients with relapsed or refractory MCL who had previously received anthracycline or bendamustine-containing chemotherapy, anti-CD20 antibody therapy and a Bruton tyrosine kinase inhibitor (ibrutinib or acalabrutinib).
According to the company, the primary endpoint was objective response rate (ORR) per the Lugano Classification (2014), defined as the combined rate of CR and partial responses as assessed by an Independent Radiologic Review Committee (IRRC).
At present, the KTE-X19 is under assessment in the European Union and has secured priority medicines (PRIME) designation from the European Medicines Agency for relapsed or refractory MCL.
Additionally, Tecartus is being evaluated in phase 1/2 trials in acute lymphoblastic leukaemia (ALL) and chronic lymphocytic leukaemia (CLL).
Kite will manufacture the Tecartus at its commercial manufacturing facility in El Segundo, California.
Kite CEO Christi Shaw said: “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.”
Recently, Gilead Sciences agreed to invest up to $300m to acquire a 49.9% equity stake in clinical-stage immunotherapy company Tizona Therapeutics.