EMA Accepts Byondis’ Application of Trastuzumab Duocarmazine for HER2-Positive Breast Cancer

The European Medicines Agency has accepted Byondis’ application for its investigational drug trastuzumab duocarmazine for treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive unresectable locally advanced or metastatic breast cancer.

The application for the antibody drug conjugate, also known as SYD985, was supported by results from a phase 3 study, which met its primary endpoint of progression-free survival, with improvements of 2.1 months in survival compared with the physician’s choice of alternate treatments.

In May, Dutch biopharma Byondis inked an exclusive licensing deal with Germany-based medac to commercialize SYD985 in the EU, the UK and further European countries, for all approved indications.

The drug candidate is also under review by the FDA.