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# Synthon Gains Fast Track for Breast Cancer Therapy
- URL: https://www.fdaweb.com/synthon-gains-fast-track-for-breast-cancer-therapy/
- Published: 2018-01-25T12:00:00.000Z
- Updated: 2026-09-14T23:16:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140605

FDA has granted Synthon Biopharmaceuticals a fast track designation for its investigational anti-HER2 antibody-drug conjugate \[vic-\]trastuzumab duocarmazine (SYD985). The 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. It was based on data from heavily pre-treated last-line HER2-positive metastatic breast cancer patients participating in a two-part Phase 1 clinical trial (SYD985.001). The clinical results show that the HER2-targeting antibody-drug conjugate is efficacious and safe and could therefore provide substantial benefit to patients with no other treatment options, the company says.