TOKYO, July 31, 2026
Daiichi Sankyo and AstraZeneca announced that the European Commission (EC) has approved Datroway® (datopotamab deruxtecan) as monotherapy for the first-line treatment of adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval is based on positive results from the Phase 3 TROPION-Breast02 trial, where Datroway became the only TROP2-directed antibody-drug conjugate (ADC) in the European Union to demonstrate a statistically significant overall survival benefit in this patient population. The therapy is now approved for two breast cancer indications in the EU, further strengthening the companies’ oncology portfolio and providing a new treatment option for patients with one of the most aggressive forms of breast cancer.
Phase 3 Trial Demonstrates Significant Survival Benefit
The TROPION-Breast02 Phase 3 trial enrolled patients with previously untreated locally recurrent inoperable or metastatic TNBC who were not eligible for immunotherapy. Datroway demonstrated a 5.0-month improvement in median overall survival, with patients achieving 23.7 months versus 18.7 months for investigator’s choice of chemotherapy. The treatment also reduced the risk of disease progression or death by 43%, while improving median progression-free survival to 10.8 months compared with 5.6 months for chemotherapy. Additionally, objective response rates reached 62.5%, more than doubling the 29.3% observed with standard chemotherapy. These results established Datroway as a clinically meaningful advancement for patients with limited first-line treatment options.
Regulatory Recognition Strengthens Clinical Position
The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and publication of the pivotal trial results in Annals of Oncology. Based on the clinical evidence, Datroway has also been incorporated into the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines as a Category IA preferred first-line treatment option for eligible metastatic TNBC patients and received an ESMO Magnitude of Clinical Benefit Scale (MCBS) score of four out of five. Company executives emphasized that the approval reflects the therapy’s potential to extend survival while addressing a significant unmet medical need for the approximately 70% of metastatic TNBC patients who are not candidates for immunotherapy.
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Global Development Continues Across Multiple Cancer Types
Datroway is a TROP2-directed DXd antibody-drug conjugate jointly developed and commercialized by Daiichi Sankyo and AstraZeneca using Daiichi Sankyo’s proprietary DXd ADC technology platform. Beyond metastatic TNBC, the therapy is already approved in multiple countries for HR-positive, HER2-negative breast cancer and EGFR-mutated non-small cell lung cancer, with additional regulatory reviews ongoing in China, Japan, Australia, Canada, Singapore, and Switzerland. The companies continue to advance an extensive global clinical development program involving more than 20 clinical trials, including multiple Phase 3 studies across breast cancer, lung cancer, and urothelial cancer, reinforcing Datroway’s role as a key component of next-generation precision oncology.
Source: Daiichi Sankyo press release
