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 and AstraZeneca. The validation confirms the completion of the application and commences the scientific review process by the EEMA's Committee for Medicinal Products for Human Use (CHMP).
The application is based on data from the DESTINY-Breast09 phase 3 trial presented during a speciallate-breaking oral session at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting and subsequently published in The New England Journal of Medicine. In the trial, ENHERTU in combination with pertuzum AB 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. Designed using Daiichi Sankyo's proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca's ADC scientific platform.
ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. ENHERTU (5.4 mg/kg) in combination with pertuzUMab is approved in the U.S. as a first-line treatment For adult patients with unresectable and metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY -Breast09 trial. ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unre intersectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from theDESTINY-Breast03 trial.
ENHERTU(5.4 mg/kg). ENHERTU (5.,4 mg/kg) is approval in more than 90 countries/Regions worldwide for the treatment of adults with unresectable or metastatics HER2 low (IHC1+ or IHC 2+ or ISH+) breast cancer who have received a previous anti-HER2-based therapy in the metastatic setting or developed disease recurrence during or Within six months of completing adjuvant chemotherapy based on the results from the dESTINY-Breast04 trial.
