CAMBRIDGE, UK & TOKYO, Japan, June 26, 2026
AstraZeneca and Daiichi Sankyo have moved one step closer to expanding treatment options for patients with metastatic triple-negative breast cancer (TNBC) after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Datroway® (datopotamab deruxtecan) as a first-line monotherapy for adults with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. The positive recommendation is supported by compelling findings from the Phase III TROPION-Breast02 clinical trial, where Datroway achieved statistically significant improvements in both overall survival (OS) and progression-free survival (PFS) compared with standard chemotherapy. If the European Commission grants final approval, Datroway could become the first TROP2-directed antibody-drug conjugate (ADC) in the European Union to demonstrate an overall survival benefit in the first-line treatment setting, offering a major advancement for patients facing one of the most aggressive forms of breast cancer.
Phase III Trial Demonstrates Superior Survival Benefits
The TROPION-Breast02 Phase III trial delivered robust clinical evidence supporting the CHMP’s recommendation. Datroway extended median overall survival to 23.7 months, compared with 18.7 months for standard chemotherapy, representing a 5.0-month survival improvement and a 21% reduction in the risk of death. The investigational therapy also reduced the risk of disease progression or death by 43%, while achieving a markedly higher objective response rate of 62.5%, compared with 29.3% for chemotherapy. The safety profile remained consistent with previous Datroway studies, reinforcing its favorable benefit-risk profile. These results position Datroway as a potential new standard of care for patients with metastatic TNBC who currently have limited first-line treatment options because immunotherapy is unsuitable or unavailable.
First TROP2-Directed ADC Poised to Transform TNBC Care
Triple-negative breast cancer accounts for approximately 15% of all breast cancer diagnoses worldwide and is widely recognized as one of the most aggressive breast cancer subtypes due to its rapid progression and limited targeted treatment options. Approximately 70% of patients with metastatic TNBC are not eligible for PD-1/PD-L1 immunotherapy, leaving chemotherapy as the primary treatment approach.
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Datroway, a TROP2-directed DXd antibody-drug conjugate, specifically targets TROP2, a protein highly expressed in many solid tumors and associated with poor clinical outcomes. By delivering a potent cytotoxic payload directly to cancer cells, the therapy is designed to improve efficacy while minimizing damage to healthy tissue. If approved, Datroway would represent the first TROP2-directed ADC in Europe to demonstrate a meaningful overall survival benefit in first-line metastatic TNBC, addressing a major unmet need in oncology.
Global Regulatory Momentum Strengthens Oncology Portfolio
The positive CHMP opinion follows U.S. FDA approval of Datroway in May 2026 for the same indication, while additional regulatory reviews are ongoing in China, Japan, Australia, Canada, Singapore, and Switzerland, including submissions through Project Orbis. Developed using Daiichi Sankyo’s proprietary DXd antibody-drug conjugate technology and jointly commercialized by AstraZeneca and Daiichi Sankyo, Datroway forms part of one of the industry’s most advanced ADC development programs. More than 20 global clinical trials are currently evaluating the therapy across multiple solid tumors, including breast cancer, non-small cell lung cancer, and urothelial cancer.
The latest European regulatory milestone further strengthens both companies’ oncology leadership while reinforcing the growing role of antibody-drug conjugates in transforming precision cancer treatment. If granted final European Commission approval, Datroway is expected to redefine first-line treatment for eligible patients with metastatic TNBC and expand access to an innovative therapy capable of delivering meaningful survival improvements beyond conventional chemotherapy.
Source: AstraZeneca, Daiichi Sankyo press release
