Posted by Michael Wonder on 14 Feb 2020
Seattle Genetics announces FDA filing acceptance for priority review of tucatinib new drug application for patients with locally advanced or metastatic HER2-positive breast cancer
13 February 2020 - FDA Action Date is 20 August 2020; Application under FDA’s real-time oncology review and Orbis pilot programs.
Seattle Genetics today announced that the U.S. FDA has accepted for priority review the Company’s new drug application for the investigational medicine tucatinib. This applocation requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neo-adjuvant, adjuvant or metastatic setting.
The filing is based on the results of HER2CLIMB, a randomised pivotal trial comparing tucatinib added to trastuzumab and capecitabine versus trastuzumab and capecitabine alone.
