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The FDA has granted Fast Track designation for the investigational anti-HER2 antibody-drug conjugate (ADC) [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.

FDA; breast cancer. ... - Click to enlarge in new windowFDA; breast cancer. FDA; breast cancer

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 ADC is efficacious and safe and could therefore provide substantial benefit to patients with no other treatment options.


In November 2017, the pivotal phase III TULIP trial, a multi-center, open-label, randomized clinical trial comparing the efficacy and safety of the ADC [vic-]trastuzumab duocarmazine to physician's choice treatment in patients with HER2-positive unresectable locally advanced or MBC was initiated. Patients are currently being enrolled in this trial, which will be conducted in up to 100 sites in the U.S., Canada, Europe, and Singapore.