BRIEF—Kite files sBLA for Tecartus

Kite, a Gilead Sciences subsidiary, has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration 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 I/II 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.

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.