<div id="readability-page-1"><div>(Alliance News) - Daiichi Sankyo Co Ltd on Thursday said the EU has validated an application for Datroway as a first-line treatment for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy.Datroway is an antibody drug conjugate discovered by Tokyo-based pharmaceutical maker Daiichi Sankyo. It is being jointly developed and commercialised with Cambridge, England-based AstraZeneca PLC.The validation confirms the completion of the application and starts the scientific review process by the European Medicines Agency's Committee for Medicinal Products for Human Use.In April, the drug was approved in the EU to treat adult patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. The application is based on data from the Tropion-Breast02 phase three trial.In the trial, Datroway demonstrated a statistically significant and clinically meaningful improvement for overall survival and progression-free survival compared to chemotherapy.&#34;Datroway has shown the potential to replace traditional chemotherapy and improve survival for patients with metastatic triple negative breast cancer, the most aggressive type of breast cancer with one of the worst prognoses,&#34; said Ken Takeshita, head of research &amp; development at Daiichi Sankyo.&#34;This EMA validation represents the potential for a second indication for Datroway in breast cancer and another step forward in the approval process in Europe.&#34;Daiichi Sankyo said additional regulatory submissions for Datroway in this indication are underway globally.Shares in Daiichi Sankyo closed down 3.5% at JPY3,341.00 on Thursday in Tokyo. AstraZeneca shares were down 0.6% at 13,476.00 pence in London.By Michael Hennessey, Alliance News reporterComments and questions to newsroom@alliancenews.comCopyright 2025 Alliance News Ltd. All Rights Reserved.</div></div>

阿斯利康制藥

第一三共株式會社(ADR)

阿斯利康

第一三共株式會社 (ADR) 和阿斯利康已申請歐盟批准將 Datroway 作為轉移性三陰性乳腺癌的一線治療藥物。該申請已獲得驗證，啓動了科學審查過程。Datroway 在試驗中顯示出顯著的生存率改善。這標誌着 Datroway 在乳腺癌治療中的潛在第二個適應症。公告發布後，兩家公司股價略有下跌

第一三共株式會社 (ADR) 和阿斯利康為 Datroway 申請第二次歐盟批准