Datroway Wins EU Approval for First-Line Metastatic Triple-Negative Breast Cancer

The European Commission has approved datopotamab deruxtecan (Datroway), an antibody-drug conjugate (ADC), as monotherapy for the 1st-line treatment of adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitor therapy, AstraZeneca and Daiichi Sankyo announced.¹ The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and is based on results from the phase 3 TROPION-Breast02 trial.

"For people living with metastatic triple-negative breast cancer, every new treatment option matters," 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 TROPION-Breast02 investigator, in a company press release.¹ "Despite recent advances, more than two-thirds of patients are not candidates for immunotherapy and have had limited options beyond chemotherapy."

What did the TROPION-Breast02 trial show?

In the trial, which enrolled 644 patients, including those who experienced early relapse following prior treatment, datopotamab deruxtecany produced a statistically significant 5.0-month improvement in median overall survival (OS) versus chemotherapy (23.7 months vs 18.7 months; hazard ratio [HR] 0.79; 95% confidence interval [CI], 0.64-0.98; p=.0291).^1,2 The ADC also reduced the risk of disease progression or death by 43% (HR 0.57; 95% CI, 0.47-0.69; p<.0001) as assessed by blinded independent central review, and produced a higher objective response rate than chemotherapy (62.5% vs 29.3%).^1,2

Based on these results, datopotamab deruxtecan has been included in the ESMO Clinical Practice Guidelines as a Category IA 1st-line option for patients with metastatic TNBC who are not immunotherapy candidates, and received a score of 4 out of 5 on the ESMO Magnitude of Clinical Benefit Scale.¹ The safety profile in TROPION-Breast02 was consistent with prior datopotamab deruxtecan trials in breast cancer.

What is the disease burden of triple-negative breast cancer?

TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 365,000 diagnoses worldwide and roughly 81,000 in Europe each year.³ It tests negative for estrogen receptors, progesterone receptors, and HER2 overexpression, making it more difficult to treat than other breast cancer subtypes, and is diagnosed more often in younger and premenopausal women.³ Metastatic TNBC carries a median OS of just 12 to 18 months, with only about 15% of patients surviving 5 years after diagnosis; approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy, for whom chemotherapy has remained the standard 1st-line treatment.^1,4

How does datopotamab deruxtecan work, and where else is it approved?

Datopotamab deruxtecan is a TROP2-directed ADC built on Daiichi Sankyo's DXd ADC technology, combining a humanized anti-TROP2 antibody with a topoisomerase I inhibitor payload via a cleavable linker.¹ It is already approved in more than 45 countries for HR-positive, HER2-negative metastatic breast cancer following prior endocrine therapy and chemotherapy, based on the TROPION-Breast01 trial, and received US approval for the same TNBC indication in May 2026; additional regulatory reviews are underway in China, Japan, and several countries under Project Orbis.¹ In the United States, datopotamab deruxtecan also holds accelerated approval for epidermal growth factor receptor-mutated non-small cell lung cancer, contingent on confirmatory trial data.¹

What are the limitations?

TROPION-Breast02 was open-label rather than blinded for treatment assignment, though its dual primary endpoints were centrally and independently reviewed. The trial population included patients with poor prognostic factors such as stable brain metastases, and whether the survival benefit is sustained will depend on continued follow-up and real-world evidence.

References

1. AstraZeneca; Daiichi Sankyo. Datroway approved in the EU as only TROP2-directed medicine with overall survival benefit for the 1st-line treatment of patients with metastatic TNBC who are not candidates for immunotherapy. Press release. Published July 31, 2026. Accessed July 31, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/datroway-approved-in-eu-for-tnbc.html
2. Dent R, Shao Z, Schmid P. Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial. Ann Oncol. 2026;37(8):1066-1080. doi:10.1016/j.annonc.2026.03.008
3. World Health Organization. Global status report on cancer 2026: the future we choose together. July 8, 2026. Accessed July 31, 2026. https://www.who.int/publications/i/item/9789240123977
4. American Cancer Society. Triple-negative breast cancer. Accessed July 31, 2026. https://www.cancer.org/cancer/types/breast-cancer/about/types-of-breast-cancer/triple-negative.html