CARsgen Receives Approval for Satri-cel in Claudin18.2-Positive Gastric Cancer
Monday, March 03, 2025
CARsgen Therapeutics has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to satricabtagene autoleucel (satri-cel, CT041).
Claudin18.2-positive gastric cancer is a subtype of gastric cancer characterised by the overexpression of the Claudin18.2 (CLDN18.2) protein. Claudin18.2 is a tight junction protein normally restricted to gastric epithelial cells but becomes exposed in certain cancers, making it a promising target for therapy.
Satri-cel is an autologous CAR T-cell therapy designed to target Claudin18.2-positive solid tumours. It has the potential to be the first therapy of its kind globally.
The treatment focuses primarily on gastric, gastroesophageal junction, and pancreatic cancers.
The designation applies to the treatment of Claudin18.2-positive advanced gastric and gastroesophageal junction (G/GEJ) cancer in patients who have previously undergone at least two lines of therapy.
The company is preparing to submit a New Drug Application (NDA) for satri-cel to the NMPA in the first half of 2025.
The BTD status is expected to accelerate the regulatory process and facilitate earlier access to the treatment for patients.
Source: carsgen.com
