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AstraZeneca and Daiichi Sankyo's Datroway Approved by FDA for HR-Positive, HER2-Negative Advanced Breast Cancer Based on Phase III Trial

Jan 21, 2025, 12:00 PM

AstraZeneca and Daiichi Sankyo have received U.S. Food and Drug Administration (FDA) approval for their drug Datroway (datopotamab deruxtecan, or Dato-DXd) for the treatment of adults with previously treated, unresectable, or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The approval is based on the results of the TROPION-Breast01 Phase III trial, which showed a significant reduction in the risk of disease progression or death compared to chemotherapy. Datroway targets TROP2, a protein found on many cancer cells, and represents a new treatment option for patients who have progressed after endocrine-based therapy and chemotherapy. The drug is administered intravenously at a dose of 6 mg/kg once every 21 days. Daiichi Sankyo's stock rose the most in five months following the approval, reflecting the market's positive reception of this milestone in the company's efforts to develop a widely used blockbuster treatment.