FDA Approves Datopotamab Deruxtecan With Improved PFS for Advanced HR+/HER2- Breast Cancer

Jan 17, 2025, 12:23 PM

The FDA has approved datopotamab deruxtecan (Datroway) for the treatment of unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer in adults who have previously received endocrine-based therapy and chemotherapy. The approval is supported by the TROPION-Breast01 trial, which showed a median progression-free survival of 6.9 months for Datroway compared to 4.9 months for chemotherapy (HR, 0.63). The trial also reported a median overall survival of 18.6 months for Datroway versus 18.3 months for chemotherapy. Common adverse effects included stomatitis, nausea, and fatigue. Datopotamab deruxtecan is co-developed by AstraZeneca and Daiichi Sankyo, marking a significant advancement in targeted cancer therapies.