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 the FDA on the review of this application.” Tucatinib is an oral investigational small molecule that potently blocks the HER2 receptor. Since it is able to cross the blood-brain barrier — a highly selective, protective membrane that prevents large molecules in the blood from reaching the brain — tucatinib has the potential to fight brain metastases in people with HER2-positive cancers. The therapy has received the FDA’s orphan drug designation for the treatment of breast cancer patients with brain metastases. It also earned the FDA’s breakthrough therapy designation, in combination with trastuzumab and Xeloda, for locally advanced inoperable or metastatic HER2-positive breast cancer patients who had received prior treatment with trastuzumab, Perjeta, and Kadcyla. These design
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