Datroway® is the commercial brand name of Datopotamab Deruxtecan for Injection (Chinese brand name: Dazhuoyou / 达卓优 ®), a TROP2-targeted antibody-drug conjugate (ADC) co-developed by Daiichi Sankyo and AstraZeneca. Constructed with Daiichi Sankyo’s proprietary DXd ADC platform, it consists of a humanized anti-TROP2 monoclonal antibody conjugated to a topoisomerase I inhibitor payload. After binding to TROP2-overexpressing tumor cells, the ADC is internalized to release cytotoxic payload to trigger tumor cell apoptosis and suppress tumor growth. The product must be reconstituted and diluted prior to intravenous infusion.
Main Indications
For the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who have received prior endocrine therapy and at least one line of chemotherapy for advanced disease.
Clinical Research
Global multicenter Phase III pivotal trial TROPION-Breast01 confirmed that datopotamab deruxtecan reduced the risk of disease progression or death by 37% versus single-agent chemotherapy selected by physicians, delivering durable tumor shrinkage and prolonged overall survival;
Domestic registration clinical trials enrolling Chinese breast cancer patients demonstrated consistent anti-tumor efficacy and safety data consistent with global multi-center trial outcomes;
Phase III TROPION-Breast02 study validated significant overall survival benefit for metastatic triple-negative breast cancer patients ineligible for immune checkpoint inhibitors, supporting further indication expansion.
Common Side Effects
Common adverse reactions include nausea, fatigue, alopecia, stomatitis, dry eye and neutropenia;
Interstitial lung disease (ILD) is a critical adverse event requiring regular lung function surveillance during treatment; most gastrointestinal and hematologic toxicities can be controlled by treatment interruption, dose reduction and supportive care.
Approval Status in China
Datroway® (Dazhuoyou®, 100mg per vial) obtained NMPA marketing approval in August 2025, and launched commercial distribution nationwide on April 22, 2026.
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