RegulatoryJul 31, 2026, 06:56 AM
AstraZeneca's Datroway EU Approval for Metastatic TNBC
AI Summary
AstraZeneca and Daiichi Sankyo's Datroway (datopotamab deruxtecan) has received approval in the European Union for the 1st-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. This approval is based on the TROPION-Breast02 Phase III trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival and progression-free survival. Datroway is now the only TROP2-directed antibody drug conjugate approved in the EU with an overall survival benefit for this patient population, offering a new treatment option for an aggressive disease.
Key Highlights
- Datroway approved in EU for 1st-line metastatic triple-negative breast cancer (TNBC).
- Approval based on TROPION-Breast02 Phase III trial results.
- Median overall survival improved by 5.0 months (23.7 vs 18.7 months).
- Reduced risk of disease progression or death by 43% (HR 0.57).
- Objective response rate was 62.5% for Datroway vs. 29.3% for chemotherapy.
- Datroway is the only TROP2-directed ADC with overall survival benefit in EU for this indication.
- Included in ESMO Clinical Practice Guidelines as Category IA 1st-line treatment.
- Already approved in the US for the same indication in May 2026.
Price Impact
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