China Approves World’s First CAR T-Cell Therapy for Solid Tumors

China’s National Medical Products Administration recently approved satricabtagene autoleucel (satri-cel, CARsgen), making it the world’s first chimeric antigen receptor (CAR) T-cell therapy approved for the treatment of a solid tumor.

The therapy is an autologous treatment indicated for patients with Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy. Satri-cel targets Claudin18.2, a protein expressed in several gastrointestinal cancers.

The approval was supported by a phase 2 trial demonstrating improved progression-free survival compared with physician's choice of treatment