Posted by Michael Wonder on 18 Oct 2022
CARsgen announces NDA acceptance of BCMA CAR T zevor-cel (CT053) by China NMPA
18 October 2022 - CARsgen Therapeutics announces that the NMPA of China has accepted the new drug application for zevorcabtagene autoleucel ("zevor-cel," CT053), a fully human, autologous BCMA CAR T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma.
The acceptance of the NDA is based on data from an open-label, single arm Phase I/II clinical trial (LUMMICAR STUDY 1 [Protocol number CT053-MM-01]) in China.
