Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer

CAR-T Digest - August 2020

13 Aug 2024: Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China for treating adults with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have undergone two or more prior treatment regimens
The approval is based on positive results from the DESTINY-Gastric06 Phase II trial, which showed Enhertu’s efficacy in this patient population. Full approval will depend on further confirmatory clinical trials demonstrating clinical benefit
The DESTINY-Gastric06 trial reported an objective response rate (ORR) of 28.8% and a median progression-free survival (PFS) of 5.7 months, with no new safety concerns identified
Enhertu has already been approved for advanced or metastatic gastric cancer in over 45 countries, including the US, Japan, and the EU. This new approval marks the third indication for Enhertu in China within two years