Posted by Michael Wonder on 30 May 2019
Zymeworks' lead asset, ZW25, granted fast track designation from the FDA
29 May 2019 - Zymeworks today announced that the U.S. FDA has granted fast track designation to ZW25, a novel azymetric bispecific antibody, for the first-line treatment of patients with HER2 over-expressing gastro-esophageal adenocarcinoma in combination with standard of care chemotherapy.
The Phase 2 trial is a two-part open-label study. The primary objectives of this trial are to confirm the safety, tolerability, and anti-tumor activity of ZW25 in combination with global standard of care regimens for gastroesophageal adenocarcinoma, including platinum and fluoropyrimidine-based regimens.
