FDA green lights another Kite CAR-T therapy, Tecartus for MCL

The US Food and Drug Administration 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 drug was developed by Kite, now a subsidiary of Gilead Sciences (Nasdaq: GILD) as a result of its $11.9 billion acquisition in 2017, and will carry a US list price will of $373,000 per one-time infusion.

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% of patients responded to a single infusion of Tecartus, including 62% of study subjects achieving a complete response (CR). Among patients evaluable for safety, 18% experienced Grade 3 or higher cytokine release syndrome (CRS) and 37% experienced Grade 3 or higher neurologic toxicities.