FDA Approves Tecartus for Acute Lymphoblastic Leukemia

The FDA has granted approval for Kite’s Tecartus (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Kite is a Gilead company.

The agency had previously given the gene therapy breakthrough therapy designation and priority review. Tecartus is the first chimeric antigen receptor (CAR) T-cell therapy approved for adults with ALL. Patients can access Tecartus through 109 authorized treatment centers across the United States.

The approval is based on results from ZUMA-3, a global study in which 65% of the evaluable patients achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) at a median actual follow-up of 12.3 months. Among efficacy-evaluable patients, the median duration of remission was 13.6 months. Grade 3 or higher cytokine release syndrome (CRS) and neurologic events occurred in 26% and 35% of patients, respectively, and were generally well-managed.

This approval is the fourth indication for the anti-CD19 CAR T-cell therapy and the first in leukemia. Tecartus uses the XLP manufacturing process that includes T cell enrichment, a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. Tecartus is also being evaluated in pediatric ALL.

Bijal Shah, M.D.

“We now have a new meaningful advancement in treatment for these patients. A single infusion of Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care,” Bijal Shah, M.D., ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center in Tampa, said in a statement.

ALL is an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs. Survival rates remain very poor in adult patients with relapsed or refractory ALL, with median overall survival at less than eight months. The National Cancer Institute estimates there will be almost 5,700 new cases of ALL diagnosed in 2021 and an estimated 1,500 deaths this year.