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.
About Byondis
Byondis started its biopharmaceutical activities in 2007. In 2012, the company became a new biopharmaceutical subsidiary and quickly built a promising pipeline of innovative research and development programs. After becoming an independent company in November 2019, the clinical stage biopharmaceutical company rebranded itself as Byondis in April 2020. Byondis, a subsidiary of the holding company Arcory B.V., still operates under the leadership of its original founder, Jacques Lemmens, PhD.
July 19, 2022
