FDA Grants Synthon Fast Track Designation for Anti-HER2 ADC for Pre-treated HER2-positive Metastatic Breast Cancer
29 January 2018 - - The US Food and Drug Administration has granted fast track designation for Nijmegen, the Netherlands-based generic medicines pharmaceutical company Synthon Biopharmaceuticals' investigational anti-HER2 antibody-drug conjugate [vic-]trastuzumab duocarmazine (SYD985), the company said.
This designation is for treating patients diagnosed with HER2-positive metastatic breast cancer that has progressed during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease, or progressed during or after [ado-]trastuzumab emtansine treatment.
The designation was granted based on promising data from heavily pre-treated last-line HER2-positive MBC patients participating in a two-part Phase I clinical trial.
The positive clinical results indicate that this HER2-targeting ADC is efficacious and safe and could therefore provide substantial benefit to patients with no other treatment options.
Synthon is focusing on the therapeutic areas of oncology and auto-immune diseases. Its products are currently approved by regulatory agencies in over 90 countries worldwide and marketed through strategic partnerships and in dedicated areas through direct sales.
The company employs about 1,900 staff worldwide, and recorded a turnover of EUR 258 m in 2016.