RegulatoryJun 29, 2026, 06:11 AM
AstraZeneca's Datroway Recommended for EU Approval in TNBC
AI Summary
AstraZeneca and Daiichi Sankyo's Datroway has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for approval in the European Union. The recommendation is for Datroway as a 1st-line monotherapy for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. This decision is based on the TROPION-Breast02 Phase III trial, which showed statistically significant and clinically meaningful improvements in overall survival and progression-free survival, with Datroway demonstrating a 5.0-month increase in median OS and a 43% reduction in disease progression risk compared to chemotherapy.
Key Highlights
- AstraZeneca and Daiichi Sankyo's Datroway recommended for approval in the EU by CHMP.
- Indication: 1st-line treatment for adult patients with unresectable or metastatic TNBC not candidates for PD-1/PD-L1 inhibitor therapy.
- Recommendation based on TROPION-Breast02 Phase III trial results.
- Datroway demonstrated a 5.0-month improvement in median overall survival (OS) compared to chemotherapy.
- Median OS was 23.7 months for Datroway vs 18.7 months for chemotherapy.
- Datroway reduced the risk of disease progression or death by 43% (HR 0.57).
- Objective response rate (ORR) was 62.5% for Datroway compared to 29.3% for chemotherapy.
- Datroway was approved in the US in May 2026 for the same indication.
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