Enhertu approved in China as first HER2 directed medicine for patients with HER2 low or HER2 ultralow metastatic breast cancer following disease progression after one or more endocrine therapies

CAR-T Digest - August 2020

Weekly Digest - December 2025

25 December 2025: Enhertu approved in China as first HER2 directed medicine for patients with HER2 low or HER2 ultralow metastatic breast cancer following disease progression after one or more endocrine therapies

China’s National Medical Products Administration approved Enhertu for adults with unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer after progression on one or more endocrine therapies, marking its first approval in this patient group
The decision is based on results from the Phase 3 DESTINY-Breast06 trial, where Enhertu significantly improved progression-free survival versus chemotherapy in chemotherapy-naive HR-positive, HER2-low metastatic breast cancer
Enhertu reduced the risk of disease progression or death by 38% and achieved a median PFS of 13.2 months versus 8.1 months with chemotherapy, alongside higher objective response rates and longer response duration
In patients with HER2-ultralow disease, Enhertu also showed clinically meaningful improvements in PFS and response rates compared with chemotherapy, broadening the eligible treatment population
Developed by Daiichi Sankyo and AstraZeneca, this marks the fifth approval for Enhertu in China across three tumour types in under three years, bringing the drug earlier into the treatment pathway