Kite announced that it received conditional approval in Europe for Tecartus (brexucabtagene autoleucel). Tecartus is a chimeric antigen receptor (CAR) T cell therapy approved for treating adult patients with relapsed or refractory mantle cell lymphoma. Tecartus is administered after two systemic treatments, including Bruton’s tyrosine kinase (BTK) inhibitor.
The approval is based on the Phase II open-label ZUMA-2 pivotal trial. The enrolled patients were previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy, and a BTK inhibitor. 93% of patients demonstrated an overall response rate, 67% of patients achieved completed response. 15% of patients experienced Grade 3 or higher cytokine release syndrome (CRS), and 33% experienced neurological events.
Tecartus is a CAR-T cell therapy XLP manufacturing process that includes T cell enrichment. The product has received the PRIME designation from EMA. Currently, the product has received conditional approval for one year.