Kite submits sBLA to FDA for Tecartus in adult patients with relapsed or refractory acute lymphoblastic leukemia.

Kite, a Gilead Company announced that it has submitted a supplemental Biologics License Application (sBLA) to the 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/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.