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AstraZeneca : Datroway recommended for approval in the EU by CHMP as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy
AstraZeneca : Datroway recommended for approval in the EU by CHMP as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not
About this update from Astrazeneca Plc
Recommendation based on TROPION-Breast02 Phase III trial where AstraZeneca and Daiichi Sankyo's Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survivalIf approved, Datroway has the potential to be the first TROP2-directed antibody drug conjugate for patients in the EU with a demonstrated overall survival benefit as 1st-line treatment AstraZeneca and Daiichi Sankyo's Datroway (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy 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. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast02 Phase III trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "As one of the hardest cancers to treat, today only 15% of patients with metastatic triple-negative breast cancer survive beyond five years. This positive opinion from the CHMP marks an important step forward in bringing the potential of Datroway to transform outcomes for patients with this type of cancer in the EU." John Tsai, MD, Global Head, R&D, Daiichi Sankyo, said: "Triple-negative breast cancer remains one of the most aggressive types of breast cancer, with limited treatment options for patients with metastatic disease who are not candidates for immunotherapy and are currently treated with traditional chemotherapy. This positive recommendation by the CHMP underscores the potential for Datroway to replace traditional chemotherapy in this setting and we look forward to working closely with the EMA to bring this new indication to patients in the EU." In the trial, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0291) compared to chemotherapy as 1st-line treatment in this patient population. Median OS was 23.7 months for patients treated with Datroway versus 18.7 months for thos...