AstraZeneca and Daiichi Sankyo have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Datroway (datopotamab deruxtecan) as a first-line monotherapy for adults with unresectable or metastatic Triple-Negative Breast Cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

The positive opinion is based on results from the Phase 3 TROPION-Breast02 clinical trial, which demonstrated that Datroway significantly improved overall survival and progression-free survival compared with standard chemotherapy. Findings from the study were presented at the 2025 European Society for Medical Oncology (ESMO) Congress and published in the Annals of Oncology.

According to the trial results, patients treated with Datroway achieved a median overall survival of 23.7 months compared with 18.7 months for those receiving chemotherapy, representing a statistically significant improvement of five months. The therapy also reduced the risk of disease progression or death by 43 percent and recorded an objective response rate of 62.5 percent, compared with 29.3 percent for chemotherapy. The safety profile of Datroway was found to be consistent with previous clinical studies in breast cancer.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca, said the CHMP recommendation marks an important milestone in bringing a potential new treatment option to patients with one of the most difficult-to-treat forms of breast cancer. She noted that only around 15 percent of patients with metastatic triple-negative breast cancer survive beyond five years.

John Tsai, Global Head of R&D at Daiichi Sankyo, said the recommendation highlights Datroway's potential to replace traditional chemotherapy for patients who are not eligible for immunotherapy, addressing a significant unmet medical need in metastatic TNBC.

Datroway received approval in the United States in May 2026 for the same indication, while regulatory reviews are ongoing in China, Japan, Australia, Canada, Singapore and Switzerland under Project Orbis. The therapy is a TROP2-directed antibody-drug conjugate jointly developed and commercialised by AstraZeneca and Daiichi Sankyo, combining targeted delivery with Daiichi Sankyo's proprietary DXd technology.

Triple-negative breast cancer accounts for approximately 15 percent of all breast cancer cases worldwide, with an estimated 345,000 new diagnoses each year. The disease is particularly aggressive and lacks the hormone and HER2 receptors that are targeted by many existing therapies, making treatment more challenging. Approximately 70 percent of patients with metastatic TNBC are not eligible for immunotherapy and have traditionally relied on chemotherapy as the standard first-line treatment.

Datroway is currently being evaluated in a broad global clinical development programme involving more than 20 studies across multiple cancer types, including breast, lung and urothelial cancers, as AstraZeneca and Daiichi Sankyo continue to expand its potential clinical applications.