- The US Food and Drug Administration (FDA) has granted accelerated approval to brexucabtagene autoleucel (Tecartus) for the treatment of adults with relapsed or refractory mantle cell lymphoma (R/R MCL).
- The recommended dose is 2×106 chimeric antigen receptor (CAR)-positive viable T cells per kilogram body weight, with a maximum of 2×108 CAR-positive viable T cells.
Why this matters
- Brexucabtagene autoleucel is the first approved CAR T cell therapy for the treatment of R/R MCL.
- The approval is based on data from the ongoing, single-arm ZUMA-2 pivotal trial.
- The trial enrolled 74 patients with MCL who were previously treated with anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy, and a Bruton tyrosine kinase inhibitor.
- The objective response rate among patients evaluable for efficacy was 87%.
- 62% of patients had a complete response.
- The median duration of response has not yet been reached.
- The most common ≥grade 3 adverse reactions included anemia, neutropenia, thrombocytopenia, hypotension, hypophosphatemia, encephalopathy, leukopenia, hypoxia, pyrexia, hyponatremia, hypertension, infection-pathogen unspecified, pneumonia, hypocalcemia, and lymphopenia.
- Of the patients evaluable for safety, 18% had ≥grade 3 cytokine release syndrome and 37% had neurologic events.
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