FDA Grants Breakthrough Therapy Status to Tucatinib for Advanced HER2-Positive Breast Cancer

FDA Grants Breakthrough Therapy Status to Tucatinib for Advanced HER2-Positive Breast Cancer
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Seattle Geneticstucatinib, in combination with trastuzumab and Xeloda (capecitabine), for the treatment of patients with locally advanced inoperable or metastatic HER2-positive breast cancer. The designation, which also includes those with brain metastases, is for patients who previously received treatment with three other HER2-targeted therapies: trastuzumab (sold under the brand name Herceptin, among others), Perjeta (pertuzumab) and Kadcycla (ado-trastuzumab emtansine). Breakthrough designation is given to medications that have the potential to provide significant advantages over currently available options. It is intended to accelerate the development, review, and approval of treatments for serious or life-threatening conditions. Tucatinib is a potent oral inhibitor of the HER2 receptor that has the ability to cross the blood-brain barrier — a highly selective, semipermeable membrane that isolates the brain from the blood circulating in the body — and shows promise in fighting brain metastases in people
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