Synthon Biopharmaceutical’s investigational treatment for HER2-positive metastatic breast cancer, SYD985, has been granted Fast Track designation.

SYD985 is an anti-HER2 antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine. It is intended to treat patients diagnosed with HER2-positive metastatic breast cancer (MBC) that has progressed during or after ≥2 HER2-targeting regimens for locally advanced or metastatic disease, or has progressed during or after [ado-]trastuzumab emtansine. The Company’s differentiating linker-drug technology is based on synthetic duocarmycin analogs that bind to the minor groove of DNA and subsequently cause irreversible alkylation of DNA, leading to tumor cell death.

The Fast Track designation is based on results from a Phase 1 trial (SYD985.001) that demonstrated safety and efficacy with [vic-]trastuzumab duocarmazine in heavily pre-treated last-line HER2-positive MBC patients.

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The Company is currently enrolling patients in the Phase 3, multi-center, open-label, randomized TULIP trial to compare the efficacy and safety of SYD985 to the physician’s treatment choice in patients with HER2-positive, unresectable locally advanced or metastatic breast cancer. The primary endpoint will be superiority in progression-free survival of SYD985 to that of the physician’s choice.

“I believe that the benefit/risk balance of [vic-]trastuzumab duocarmazine is favorable and that it can provide extended benefit to these patients,” Dr. Jacques Lemmens, chief executive officer of Synthon. “Fast Track designation will support efficient development and review of [vic-]trastuzumab duocarmazine and enable early access of this promising new single-agent therapy option.”

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