25 January 2018 - Synthon Biopharmaceuticals today announced that the U.S. FDA has granted fast track designation for its investigational anti-HER2 antibody-drug conjugate [vic-]trastuzumab duocarmazine (SYD985). 

This designation is for treating patients diagnosed with HER2-positive metastatic breast cancer (MBC) 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.

Fast track designation for [vic-]trastuzumab duocarmazine 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 (SYD985.001). The positive clinical results indicate that this HER2-targeting antibody drug conjugate is efficacious and safe and could therefore provide substantial benefit to patients with no other treatment options.

Read Synthon press release