Enhertu plus pertuzumab Type II Variation application validated by EMA

The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TYO: 4568) and being jointly developed and commercialized with UK pharma major AstraZeneca (LSE: AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA’s human medicines committee, the CHMP.

The application is based on data from the DESTINY-Breast09 phase 3 trial presented during a special late-breaking oral session at the 2025 American Society of Clinical Oncology annual meeting and subsequently published in The New England Journal of Medicine. In the trial, Enhertu in combination with pertuzumab demonstrated a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for patients with HER2 positive metastatic breast cancer.