Posted by Michael Wonder on 06 Apr 2021
Kite submits supplemental biologics license application to U.S. FDA for Tecartus in adult patients with relapsed or refractory acute lymphoblastic leukaemia
1 April 2021 - If approved, Tecartus would be the first and only CAR T-cell therapy approved for adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.
Kite today announced that it has submitted a supplemental biologics license application to the U.S. FDA for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.
The supplemental biologics license application is supported by data from the Phase 1/2 ZUMA-3 trial, which are also being submitted for presentation at an upcoming scientific congress.
