The European Medicines Agency (EMA) has validated the Type II Variation application for ENHERTU® (trastuzumab deruxtecan) to treat patients with HER2 low or HER2 ultralow metastatic breast cancer who have received at least one endocrine therapy

The application is supported by the DESTINY-Breast06 phase 3 trial, which showed ENHERTU provided a significant improvement in progression-free survival compared to standard chemotherapy

ENHERTU is a HER2-directed antibody-drug conjugate developed by Daiichi Sankyo and AstraZeneca, and it is being jointly commercialized by the two companies

The EMA’s validation of the application initiates the scientific review process by the Committee for Medicinal Products for Human Use

The submission seeks to expand ENHERTU’s approval to include patients with HER2 ultralow breast cancer, with additional regulatory submissions for this indication underway globally