LONDON (dpa-AFX) - The U.S. Food and Drug Administration approved AstraZeneca (AZN, AZN.L) and Daiichi Sankyo's (DSKYF.PK) Datroway (datopotamab deruxtecan-dlnk) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
The approval was based on results from the TROPION-Breast01 Phase III trial, which showed a 37% reduction in the risk of disease progression or death compared to chemotherapy.
Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca, said,'..... We are proud to bring DATROWAY to people living with metastatic HR-positive, HER2-negative breast cancer, and this approval marks the eighth new medicine of the 20 we have set out to deliver across AstraZeneca by 2030.' Datroway is a specifically engineered TROP2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.
The companies noted that additional regulatory submissions for DATROWAY in breast cancer are under review in the EU, China and other regions.
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