Posted by Michael Wonder on 24 Jul 2020
FDA approves first cell-based gene therapy for adult patients with relapsed or refractory mantle cell lymphoma
24 July 2020 - Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma who have not responded to or who have relapsed following other kinds of treatment.
Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by the FDA for the treatment of mantle cell lymphoma.
The safety and efficacy of Tecartus was established in a multicenter clinical trial of 60 adults with refractory or relapsed MCL who were followed for at least six months after their first objective disease response. The complete remission rate after treatment with Tecartus was 62%, with an objective response rate of 87%.
