Byondis has announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for the company’s investigational next generation anti-HER2 antibody-drug conjugate.
Trastuzumab duocarmazine – also known as SYD985 – targets patients with HER2-positive unresectable locally advanced or metastatic breast cancer.
If it is granted the marketing authorisation applies to all EU member states, as well the European Economic Area countries, including Iceland, Liechtenstein and Norway. The treatment will be marketed by Byondis’ commercialisation partner and marketing authorisation applicant Medac, a privately owned pharmaceutical company based in Germany…
