Site Editor
William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Friday, July 15, 2022
The Dutch biopharmaceutical company Byondis B.V. recently announced that the U.S. Food and Drug Administration (FDA) accepted its biologics license application for [vic]-trastuzumab duocarmazine (SYD985) in patients with HER2-positive, unresectable, locally advanced, or metastatic breast cancer. This agent is a next-generation anti-HER2 antibody-drug conjugate, which consists of the anti-HER2 monoclonal antibody trastuzumab and a cleavable linker-drug called valine-citrulline-seco-duocarmycin hydroxybenzamide azaindole. The company has been given a Prescription Drug User Fee Act action date of May 12, 2023.
The application is supported by data from the phase III TULIP trial, a multicenter, open-label, randomized clinical trial that is comparing SYD985 with physician’s choice of treatment in pretreated patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer (ClinicalTrials.gov identifier NCT03262935). The study, of which the results were presented at the European Society for Medical Oncology (ESMO) 2021 Congress, met its primary endpoint of progression-free survival, demonstrating a statistically significant improvement of 2.1 months over physician’s choice of treatment. According to the manufacturer, TULIP also demonstrated supportive overall survival results.
