AstraZeneca (LSE:AZN) and Daiichi Sankyo's Datroway (datopotamab deruxtecan) has been approved in the European Union as a first-line monotherapy for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 immunotherapy.
The approval, granted by the European Commission following a positive opinion from the European Medicines Agency's advisory committee, rests on results from the Phase III TROPION-Breast02 trial presented at the 2025 European Society for Medical Oncology Congress.
Patients treated with Datroway had a median overall survival of 23.7 months, versus 18.7 months for those on chemotherapy, a statistically significant 5-month improvement.
The drug cut the risk of disease progression or death by 43% compared with chemotherapy and produced an objective response rate of 62.5%, against 29.3% for chemotherapy.
"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 treatment options in the metastatic setting", said Dave Fredrickson, AstraZeneca's Executive Vice President for Oncology Haematology.
"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."
Approximately 70% of metastatic triple-negative breast cancer patients are not candidates for immunotherapy, leaving chemotherapy as the prior standard first-line option.
Datroway, an antibody drug conjugate targeting the TROP2 protein, is now approved in the EU for two breast cancer indications and was cleared in the US for the same triple-negative indication in May.
Reviews are underway in China, Japan, Australia, Canada, Singapore and Switzerland.
News Intelligence what this means for the company
AstraZeneca and Daiichi Sankyo's Datroway has won EU approval as first-line monotherapy for metastatic triple-negative breast cancer patients ineligible for immunotherapy, following a positive EMA opinion in June. The Phase III TROPION-Breast02 trial showed a 5-month median overall survival benefit (23.7 vs 18.7 months) and a 43% reduction in disease progression or death risk versus chemotherapy, positioning Datroway as the only TROP2-directed drug with proven survival benefit in this setting—a meaningful clinical advance in a disease affecting approximately 80,000 Europeans annually, of whom roughly 70% cannot receive immunotherapy.
The EU approval expands Datroway's addressable market beyond the US clearance achieved in May and validates the drug's survival benefit in a large, underserved patient population. This strengthens AstraZeneca's oncology portfolio and supports near-term revenue growth, though the commercial impact depends on uptake in a market where chemotherapy remains the current standard for immunotherapy-ineligible patients.
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