BiotechnologyEMA Validates Marketing Authorization Application for Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer
Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company creating precision medicines, announced today that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for the company’s investigational next generation anti-HER2 antibody-drug conjugate (ADC) trastuzumab duocarmazine (SYD985) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC). If granted, the marketing authorization applies to all EU member states, as well the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. SYD985 will be marketed by...