AstraZeneca's Enhertu approved in China for advanced gastric cancer
China's National Medical Products Administration has granted conditional approval for AstraZeneca and Daiichi Sankyo's Enhertu to treat 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 adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received two or more prior treatment regimens.
The approval by the National Medical Products Administration (NMPA) is based on positive results from the DESTINY-Gastric06 Phase II trial. Full approval will depend on a subsequent randomized controlled trial demonstrating clinical benefit in this patient group. Enhertu is a HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo.
Gastric cancer is a significant health issue in China, accounting for over one third of global cases, with many diagnosed at an advanced stage. Approximately 359,000 new cases and 260,000 deaths were reported in China in 2022. Around one in five gastric cancers globally are HER2-positive.
This marks the third approval for Enhertu in China in under two years, following previous approvals for HER2-positive and HER2-low metastatic breast cancer. The companies stated that this approval provides a much-needed targeted treatment option for patients in China with HER2-positive metastatic gastric cancer.