Seattle Genetics Seeks Tucatinib’s Approval by FDA for Advanced HER2-positive Breast Cancer

Seattle Genetics Seeks Tucatinib’s Approval by FDA for Advanced HER2-positive Breast Cancer
Seattle Genetics has submitted an application requesting U.S. Food and Drug Administration (FDA) approval for its investigational therapy tucatinib, in combination with trastuzumab and Xeloda (capecitabine), for treating people with locally advanced inoperable or metastatic HER2-positive breast cancer. The new drug application, which also includes patients with brain metastases, is specific for those who have received at least three prior HER2-targeted therapies, like trastuzumab (sold under the brand name Herceptin, among others), Perjeta (pertuzumab), and Kadcycla (ado-trastuzumab emtansine). “Today’s submission marks another important milestone for Seattle Genetics and tucatinib, and a potential advance for patients with either locally advanced or metastatic HER2-positive breast cancer, including those with and without brain metastases,” Roger Dansey, MD, Seattle Genetics’ chief medical officer, said in a press release. “We look forward to working with
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