EU Approves Datroway for First-Line Triple-Negative Breast Cancer

The European Commission has approved Datroway (datopotamab deruxtecan) as a first-line treatment for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitor immunotherapy. The decision marks a significant milestone for AstraZeneca and Daiichi Sankyo, expanding treatment options for patients with one of the most aggressive forms of breast cancer.

The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is based on findings from the Phase III TROPION-Breast02 clinical trial. The study demonstrated that Datroway significantly improved both overall survival and progression-free survival compared with standard chemotherapy in the first-line setting. The results were presented at the 2025 European Society for Medical Oncology (ESMO) Congress and later published in Annals of Oncology.

Triple-negative breast cancer accounts for a smaller proportion of breast cancer diagnoses but is considered one of the most difficult subtypes to treat due to its aggressive nature and limited targeted treatment options. According to AstraZeneca, more than 80,000 people in Europe are diagnosed with TNBC each year, and many patients are not eligible for immunotherapy, leaving chemotherapy as the primary treatment option.

In the TROPION-Breast02 trial, Datroway demonstrated a median overall survival of 23.7 months, compared with 18.7 months for patients receiving chemotherapy. The treatment reduced the risk of death by 21% and achieved a statistically significant five-month improvement in overall survival.

The therapy also significantly delayed disease progression. Patients treated with Datroway experienced a 43% reduction in the risk of disease progression or death compared with chemotherapy. In addition, the antibody-drug conjugate produced a substantially higher objective response rate of 62.5%, compared with 29.3% for chemotherapy, indicating that more patients experienced meaningful tumour shrinkage.

Researchers reported that Datroway’s safety profile remained consistent with findings from earlier breast cancer studies, with no unexpected safety concerns identified during the Phase III trial.

Professor Giuseppe Curigliano, Director of the Early Drug Development Division at the European Institute of Oncology and an investigator in the TROPION-Breast02 study, said the approval provides an important new option for patients with metastatic TNBC who have historically faced limited treatment choices.

He noted that despite recent advances in breast cancer care, more than two-thirds of patients with metastatic triple-negative breast cancer are not suitable candidates for immunotherapy. According to Curigliano, the availability of Datroway represents meaningful progress for patients and families affected by the disease.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, said the approval introduces an antibody-drug conjugate with a differentiated clinical profile supported by strong survival benefits. He added that the therapy could improve outcomes for patients living with an aggressive cancer that often affects younger women.

Ken Keller, Global Head of Oncology Business and President and CEO of Daiichi Sankyo, Inc., highlighted that Datroway is currently the only TROP2-directed antibody-drug conjugate approved in the European Union to demonstrate an overall survival benefit in the first-line treatment of metastatic triple-negative breast cancer. He said the approval reflects the companies’ commitment to developing innovative medicines that address unmet needs in cancer treatment.

The strong clinical evidence has already influenced treatment recommendations. Based on the TROPION-Breast02 results, Datroway has been incorporated into the latest ESMO Clinical Practice Guidelines as a Category IA first-line treatment option for metastatic TNBC patients who are not eligible for immunotherapy. It is also listed as the preferred treatment for patients whose disease relapses within six months of completing adjuvant therapy. Furthermore, the treatment received a score of 4 out of 5 on the ESMO Magnitude of Clinical Benefit Scale, recognising its meaningful clinical benefit.

Datroway previously received approval in the United States in May 2026 for the same indication. Regulatory reviews are also ongoing in China, Japan, Australia, Canada, Singapore and Switzerland through Project Orbis, an international framework designed to accelerate the review of promising cancer therapies.

Datroway is a TROP2-directed DXd antibody-drug conjugate discovered by Daiichi Sankyo and is being jointly developed and commercialised worldwide by AstraZeneca and Daiichi Sankyo. The latest European approval further strengthens its role as an important new treatment option for patients with advanced triple-negative breast cancer.