ENHERTU® Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer [Yahoo! Finance]
DAIICHI SANKYO S/ADR (DSNKY)
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Source: Yahoo! Finance
improved progression-free survival versus current first-line standard of care in HER2 positive metastatic breast cancer TOKYO & MUNICH, January 19, 2026 BUSINESS WIRE )--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 (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA'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 special late-breaking oral session at the 202
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