FDA approval announcements and company press releases

FDA Approves Datroway for Advanced HR-Positive, HER2-Negative Breast Cancer

Jan 21, 2025, 02:03 AM

AstraZeneca and Daiichi Sankyo's new cancer drug, Datroway (datopotamab deruxtecan), has received FDA approval for treating advanced HR-positive, HER2-negative breast cancer. The drug, an antibody-drug conjugate targeting the TROP2 protein, is designed for patients whose cancer has progressed after endocrine therapy and chemotherapy. Results from the TROPION-Breast01 Phase III trial showed Datroway reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median progression-free survival of 6.9 months versus 4.9 months for chemotherapy. While the drug demonstrated significant efficacy in progression-free survival, it fell short of statistical significance in overall survival improvement. Datroway is part of AstraZeneca's broader oncology strategy, marking its eighth new medicine approved in the U.S. as part of its goal to launch 20 new drugs by 2030. The drug's approval adds to the growing list of targeted therapies for breast cancer, offering a new treatment option for patients with limited alternatives.