On July 24, 2020, the US health authority FDA approved Tecartus™ (formerly KTE-X19) a cell-based gene therapy based on the chimeric antigen receptor (CAR) technology of Kite Pharma. This makes Tecartus™ the third CAR-T cell therapy approved in the USA. It is used to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL).
With this, after the approval of Yescarta in 2017, Kite Pharma succeeded in positioning itself with a second CAR-T cell product on the ATMP market in the USA.
In the European Union, KTE-X19 is currently under evaluation in the approval process of the European Medicines Agency (EMA) and was part of the Priority Medicine (PRIME) program. We will monitor the further developments.
