AstraZeneca Receives FDA Approval for Dato-DXd in HR+/HER2- Advanced Breast Cancer

AstraZeneca and Daiichi Sankyo today announced that the FDA has approved datopotamab deruxtecan (Dato-DXd) for the treatment of adults with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy. In the Phase 3 TROPION-Breast01 trial, Dato-DXd demonstrated a statistically significant improvement in progression-free survival compared to investigator's choice chemotherapy. Dato-DXd is an antibody-drug conjugate targeting TROP2. This approval provides patients with a new ADC treatment option in HR+/HER2- breast cancer.