Posted by Michael Wonder on 13 May 2020
Seattle Genetics announces the approval of Tukysa (tucatinib) in Switzerland for the treatment of patients with metastatic HER2-positive breast cancer
12 May 2020 - First approval for Tukysa outside of the U.S.
Seattle Genetics today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted approval for Tukysa (tucatinib) tablets in combination with trastuzumab and capecitabine, for the treatment of patients with metastatic HER2-positive breast cancer, who have previously received two or more anti-HER2 regimens in any setting, including trastuzumab, pertuzumab and trastuzumab-emtansine.
The application for Tukysa approval was reviewed by Swissmedic as part of Project Orbis, an initiative of the U.S. FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international regulatory agencies in Canada, Australia and Singapore.
