Datroway cleared in the EU as the only TROP2-directed medicine with an overall survival benefit in first-line treatment of metastatic TNBC patients who are not immunotherapy candidates

AstraZeneca and Daiichi Sankyo’s Datroway has recently received approval in the European Union as a monotherapy for the first-line treatment of adults with unresectable or metastatic triple-negative breast cancer who are not suitable for PD-1/PD-L1 inhibitor therapy.

The European Commission’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency and draws on findings from the TROPION-Breast02 Phase III trial, which were shared at the 2025 European Society for Medical Oncology Congress and subsequently appeared in Annals of Oncology.

“For people living with metastatic triple-negative breast cancer, every new treatment option matters. Despite recent advances, more than two thirds of patients are not candidates for immunotherapy and have had limited options beyond chemotherapy. In my practice, I see firsthand the devastating impact this aggressive disease has on patients and their families. This approval of datopotamab deruxtecan provides a new treatment option for eligible patients and represents meaningful progress,” said Giuseppe Curigliano, MD, PhD, Director of the Early Drug Development Division, European Institute of Oncology, Professor of Medical Oncology, University of Milan, Italy, and investigator for the TROPION-Breast02 trial.

“Every year, more than 80,000 people in Europe are diagnosed with triple-negative breast cancer, a disease that often affects younger women and has limited treatment options in the metastatic setting. Today’s approval of Datroway brings an antibody drug conjugate with a differentiated clinical profile underpinned by a strong survival benefit to people with this aggressive disease,” said Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca.

“With this approval, Datroway is the only TROP2-directed antibody drug conjugate approved in the EU that has demonstrated an overall survival benefit in the 1st-line setting for the treatment of patients with metastatic triple-negative breast cancer. We look forward to bringing Datroway to patients in the EU as an additional treatment option with the potential to extend survival, reflecting our commitment to advancing innovative medicines that address unmet needs for people living with cancer,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc.

Within the trial, which enrolled patients with metastatic triple-negative breast cancer who had experienced early relapse following prior treatment, Datroway produced a statistically significant and clinically meaningful 5.0-month gain in median overall survival compared to chemotherapy as a first-line treatment. Median overall survival reached 23.7 months among those receiving Datroway against 18.7 months in the chemotherapy group. The likelihood of disease progression or death fell by 43% with Datroway relative to chemotherapy as assessed by blinded independent central review, and the therapy also generated more substantial treatment responses, with an objective response rate of 62.5% compared to 29.3% with chemotherapy.

The safety profile of Datroway in TROPION-Breast02 remained in line with findings from earlier clinical investigations of the therapy in breast cancer.

On the strength of TROPION-Breast02, Datroway has been incorporated into the ESMO Clinical Practice Guidelines as a Category IA first-line treatment option for metastatic triple-negative breast cancer patients who are not immunotherapy candidates, and is the preferred choice for those who relapsed within six months of completing adjuvant therapy. The therapy also achieved a score of 4 out of 5 on the ESMO Magnitude of Clinical Benefit Scale, reflecting the clinically meaningful gains demonstrated in the trial.

Datroway received approval in the US in May 2026 for the same patient population. Regulatory reviews are progressing in China and Japan, with additional assessments underway in Australia, Canada, Singapore, and Switzerland through Project Orbis.

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Related Topics and Keywords

AstraZeneca, Datroway, Immunology, metastatic TNBC, TROP2, TROP2-directed medicine