Tucatinib Granted FDA Priority Review for Advanced HER2-positive Breast Cancer

Tucatinib Granted FDA Priority Review for Advanced HER2-positive Breast Cancer
The U.S. Food and Drug Administration (FDA) has granted priority review to Seattle Genetics’ application seeking approval of its investigational therapy tucatinib, in combination with trastuzumab and Xeloda (capecitabine), for treating people with locally advanced inoperable or metastatic HER2-positive breast cancer. This indication applies to patients with or without brain metastases who have received at least three prior HER2-targeted therapies, such as Perjeta (pertuzumab), Kadcycla (ado-trastuzumab emtansine), and trastuzumab (sold under the brand name Herceptin, among others). The priority review status will shorten tucatinib’s regulatory review for this indication to six months from the standard 10 months. Seattle Genetics submitted the new drug application (NDA) to the FDA
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