Seattle Genetics NDA for Tucatinib in Breast Cancer

FDA has accepted for priority review a Seattle Genetics NDA for tucatinib for use in combination with trastuzumab and capecitabine for treating 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 neoadjuvant, adjuvant or metastatic setting. The agency has set a user fee review target date of 8/20.

The company says tucatinib, an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2, has shown activity as a single agent and in combination with both chemotherapy and other HER2 targeted agents such as trastuzumab. The submission is based on data from the HER2CLIMB trial that compared tucatinib added to trastuzumab and capecitabine versus trastuzumab and capecitabine alone.