SYD985 FDA Approval Status
FDA Approved: No
Brand name: SYD985
Generic name: [vic-]trastuzumab duocarmazine
Company: Byondis B.V.
Treatment for: Breast Cancer, Metastatic
SYD985 ([vic-]trastuzumab duocarmazine) is an investigational next generation anti-HER2 antibody-drug conjugate (ADC) in development for the treatment of HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).
- The SYD985 ADC is comprised of the anti-HER2 monoclonal antibody trastuzumab and a cleavable linker-drug called valine-citrulline-seco-DUocarmycin hydroxyBenzamide-Azaindole (vc-seco-DUBA).
- The antibody part of trastuzumab duocarmazine binds to HER2 on the surface of the cancer cell and the ADC is internalized by the cell. After proteolytic cleavage of the linker, the inactive cytotoxin is activated and DNA damage is induced, resulting in tumor cell death. SYD985 is considered a form of targeted therapy.
Development timeline for SYD985
|Jul 12, 2022
|FDA Accepts Byondis’ Biologics License Application for [Vic-]Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer
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