Enhertu approved in China for previously treated patients with HER2+ metastatic Solid tumors

CAR-T Digest - August 2020

Weekly Digest - October 2026

22 October 2026: Enhertu approved in China for previously treated patients with HER2+ metastatic Solid tumors

Daiichi Sankyo and AstraZeneca announced that Enhertu has received conditional approval in China as the first and only tumor-agnostic HER2-directed medicine and ADC for adults with unresectable or metastatic solid tumors expressing HER2 at IHC 3+ who have received prior treatment or have no satisfactory alternative treatment options
The approval was supported by results from four phase 2 trials: DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and DESTINY-PanTumor03. Confirmed objective response rates were 51.4%, 52.9%, 46.9% and 58.0%, respectively, across previously treated HER2 IHC 3+ solid tumors, including colorectal cancer, NSCLC and multiple other tumor types
The approval addresses an unmet need for patients with previously treated HER2-positive advanced solid tumors outside established tumor-specific indications, where treatment options can be limited and HER2-directed therapies have historically been restricted to selected cancer types. Full approval requires confirmation of clinical benefit in a confirmatory trial
Enhertu is a HER2-directed ADC comprising a monoclonal antibody linked to multiple DXd topoisomerase I inhibitor payloads through cleavable tetrapeptide-based linkers. Its tumor-agnostic approach enables targeted cytotoxic delivery to HER2-overexpressing tumor cells across different tissue origins
Strategically, the approval expands Enhertu’s tumor-agnostic reach in China and marks its sixth approval in the country in less than a year, bringing the product to 10 approved indications. It also reinforces the importance of HER2 biomarker testing and strengthens the partners’ position in precision oncology across a broader range of solid tumors