Kite, a subsidiary of Gilead Sciences, has received the US Food and Drug Administration (FDA) approval for its Tecartus (brexucabtagene autoleucel) to treat patients with relapsed or refractory b-cell acute lymphoblastic leukemia (ALL).
Tecartus, an autologous, anti-CD19 CAR T-cell therapy, uses the XLP manufacturing process that includes enrichment of T cell.
The approval makes the therapy the first and only chimeric antigen receptor (CAR) T-cell therapy approved for patients aged 18 years and above suffering with ALL.
Kite CEO Christi Shaw said: “Today marks Kite’s fourth FDA approved indication in cell therapy in under four years, demonstrating our commitment to advancing CAR T for patients across many different hematologic malignancies.
“Tecartus has already transformed outcomes for adults living with mantle cell lymphoma, and we look forward to offering the hope for a cure to patients with ALL.”
The FDA approval was based on the data obtained from a global, multicentre, single-arm, open-label ZUMA-3 trial conducted on adult patients aged 18 years and old with ALL.
It showed that 65% of the evaluable patients achieved complete remission (CR) with incomplete hematological recovery (CRi).
Adult patients suffering with relapsed or refractory ALL often undergo many treatments that include chemotherapy, targeted therapy and stem cell transplant.
The CAR T-cell therapy binds with patient’s own immune system to fight cancer.
The Leukemia & Lymphoma Society (LLS) chief scientific officer Lee Greenberger said: “Roughly half of all ALL cases actually occur in adults, and unlike pediatric ALL, adult ALL has historically had a poor prognosis.
“Developing new therapies that would be life-changing for people with cancer has been a dream of LLS.”
At present, Tecartus is under review in the UK and European Union to treat adult patients with relapsed or refractory B-cell precursor ALL.