Abstract
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).
Tecartus is the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (18 years and older) with ALL. The drug had received FDA Breakthrough Therapy Designation and a priority review for this indication.
In July 2020, the FDA approved Tecartus for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to, or who have relapsed following other kinds of treatment. Tecartus was the first cell-based gene therapy approved by the FDA for the treatment of MCL.
The drug's current approval for ALL is based on results from ZUMA-3, a global, multicenter, single-arm, open-label study in which 65% of the evaluable patients (n=54) achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) at a median actual follow-up of 12.3 months. The duration of CR was estimated to exceed 12 months for more than half the patients. Among efficacy-evaluable patients, median duration of remission (DOR) was 13.6 months.
Median overall survival (OS) from ALL is only approximately eight months with current standard-of-care treatments.
There were side effects. Among the patients treated with Tecartus at the target dose (n=78), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events occurred in 26% and 35% of patients, respectively. Kite reports these side effects “were generally well-managed.”
Tecartus is also currently under review in the European Union and United Kingdom for the treatment of adult patients with relapsed or refractory B-cell precursor ALL.