Although these drugs have not yet been marketed in China, it is important to note that the FDA's concerns are directed at "autologous CAR-T cell immunotherapy targeting BCMA or CD19." Among the four CAR-T therapies approved for marketing in China, namely Axicabtagene ciloleucel (targeting CD19) by Gilead/Fosun Kite, Relatlimab (targeting CD19) by WuXi AppTec, Idecabtagene vicleucel (targeting BCMA) by Xencor/Sinobioway, and Ciloleucel by HUYA Bioscience (targeting CD19), none are exempt from scrutiny.
The FDA stated that they received 19 reports of patients developing T-cell malignancies after CAR-T therapy, prompting a reevaluation of whether CAR-T therapy poses serious safety risks and whether there is a risk of patient hospitalization or even death.
