ERBB2 and breast carcinoma: In January 2025, the FDA approved Dato-DXd for use in patients with unresectable or metastatic, HR-positive, HER2-negative breast cancer, based on the TROPION-Breast01 trial, which demonstrated a median PFS of 6.9 months versus 4.9 months and a median OS of 18.6 months vs. 18.3 months compared to standard chemotherapy [73].