AstraZeneca (AZN), a pharmaceutical company, on Monday reported the recommendation for approval of Datroway in the European Union for the treatment of metastatic triple-negative breast cancer (TNBC).
Datroway is a TROP2-directed DXd antibody drug conjugate (ADC) that was developed by Daiichi Sankyo, and is currently being jointly developed by AstraZeneca and Daiichi. The drug targets TROP2, which is a protein broadly expressed in several solid tumors and is associated with increased tumor progression and poor survival in patients with breast cancer. Datroway received FDA approval in treating HR+/HER- breast cancer in 2025.
The Committee for Medicinal Products for Human Use (CHMP) provided the positive opinion to the European Medicines Agency (EMA) based on data from the global, multi-center, randomized, open-label Phase 3 TROPION-Breast02 trial which evaluated Datroway in patients of untreated locally recurrent inoperable or metastatic TNBC who are ineligible for PD-1/PD-L-1 inhibitor therapy.
Relative to chemotherapeutic treatments, tested subjects showed a median overall survival (OS) improved by 5 months in patients treated with Datroway. Median OS was 23.7 months in treated patients, while patients on chemotherapy survived 18.7 months. Risk of disease progression was also reduced by 43% when compared to chemotherapy.
AZN is currently trading at $189.46, up 0.56%.
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September 11, 2026 16:26 ET Consumer prices data was the main news on the economic front in the U.S. this week. In Europe, the latest interest rate decision from the European Central Bank was the focus along with the revised second quarter economic growth data for the euro area. In Asia, the monthly foreign trade data from China drew attention.