Kite, a Gilead Company announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The sBLA is supported by data from the Phase 1/2 ZUMA-3 trial, which are also being submitted for presentation at an upcoming scientific congress.
In 2017, Tecartus was granted Breakthrough Therapy Designation by the FDA for relapsed or refractory adult B-cell precursor ALL. If approved, Tecartus would become the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (≥18 years old) with relapsed or refractory ALL.
“Tecartus has already begun to transform the outlook for many patients with relapsed or refractory mantle cell lymphoma, and we’re encouraged by the data we’ve seen in adult patients with relapsed or refractory ALL, as survival rates among these patients remain poor with the most commonly used therapeutic agents,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. “We are working closely with the FDA to progress our application and to bring the benefits of CAR T to patients with this particularly intractable leukemia.”
In July 2020, Tecartus became the first and only CAR T-cell therapy to receive accelerated approval from the FDA for the treatment of relapsed or refractory mantle cell lymphoma, based on overall response rate and durability of response. The Tecartus U.S. Prescribing Information has a Boxed Warning in its product label regarding the risks of cytokine release syndrome (CRS) and neurologic toxicities, and Tecartus is approved with a risk evaluation and mitigation strategy (REMS) due to these risks; see below for Indication and Important Safety Information.
Tecartus has not been approved by any regulatory agency for the treatment of adult patients with relapsed or refractory ALL. Its safety and efficacy have not been established in this indication.