NEW YORK – Gilead company Kite said on Thursday that it has submitted a supplemental biologics license application to the US Food and Drug Administration for its autologous CAR T-cell therapy brexucabtagene autoleucel (Tecartus) as a treatment for relapsed or refractory B-cell precursor acute lymphoblastic lymphoma (ALL).
The treatment, which involves harvesting patients' immune cells, engineering them to target CD19, then reinfusing them following a lymphodepleting chemotherapy regimen, received FDA accelerated approval in mantle cell lymphoma last year.
The latest supplemental application includes data from the Phase I/II Zuma-3 trial, in which researchers evaluated 125 ALL patients for their overall complete remission rate on brexucabtagene autoleucel as the primary endpoint. Kite plans to present results from this study at an upcoming medical meeting.
"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," Frank Neumann, Kite's global head of clinical development, said in a statement. "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."