Monday, July 27, 2020 Daily Archives

Kite flies high with second CAR-T approval

Gilead’s Kite has won US FDA approval for Tecartus (brexucabtagene autoleucel), a CAR-T cell therapy for the treatment of mantle cell lymphoma (MCL). Tecartus becomes the third chimeric antigen receptor (CAR) T-cell therapy to be granted approval by the US Food and Drug Administration after Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), both of which were approved in 2017. Tecartus is designed to target CD19, a protein found in high amounts in cancerous B cells, and the regulatory decision…