By Fineline Cube Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and Gilead’s Kite Pharma, has received another clinical trial approval for its anti-CD19 chimeric antigen receptor (CAR) T therapy Yescarta (axicabtagene ciloleucel). The new indication targets adult large B-cell lymphoma (r/r LBCL) that is refractory to first-line immunochemotherapy or has relapsed within 12 months.
Background
Yescarta was approved in the US and Europe in October 2017 and August 2018, respectively, for lymphoma treatment. In China, it received conditional approval in June 2021 for relapsed or refractory large B-cell lymphoma after second-line or more systemic treatment. The same month, it also gained clinical trial approval for second-line and above relapsed or refractory indolent non-Hodgkin lymphoma (r/r iNHL) after systemic therapy. Additionally, Yescarta was granted breakthrough therapy designation (BTD) status in China in August 2021.-Fineline Info & Tech