Enhertu approved in China for HER2-positive early Breast cancer with residual disease

CAR-T Digest - August 2020

08 October 2026: Enhertu approved in China for HER2-positive early Breast cancer with residual disease

Daiichi Sankyo and AstraZeneca announced that Enhertu has been approved in China as adjuvant treatment for adults with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant taxane- and trastuzumab-based therapy, expanding its use into the post-surgical setting
The approval is based on the Phase 3 DESTINY-Breast05 trial, where Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 (HR=0.47; p<0.0001), with 3-year invasive disease-free survival of 92.4% versus 83.7%
The approval addresses a major unmet need in high-risk HER2-positive early breast cancer, where patients with residual invasive disease after neoadjuvant therapy remain at risk of recurrence despite adjuvant treatment with T-DM1, potentially progressing to incurable metastatic disease
Enhertu is a HER2-directed ADC comprising a monoclonal antibody linked to multiple topoisomerase I inhibitor DXd payloads through tetrapeptide-based cleavable linkers, enabling targeted delivery of cytotoxic payloads to HER2-expressing tumor cells
Strategically, the approval marks Enhertu’s second approval in early breast cancer in China and its fifth approval in the country in less than a year, strengthening its position across the HER2-positive treatment continuum and expanding its role in curative-intent therapy