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 Genetics’ tucatinib, 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 with HER2-positive cancers. It previously received orphan drug designation from the FDA for the treatment of breast cancer patients with brain metastases. The breakthrough designation for the treatment of advanced HER2-positive breast cancer was granted based on top-line data from the pivotal Phase 2 HER2CLIMB trial (NCT02614794). Additional findings from the trial were also recently presented at the 2019 San Antonio Breast Cancer Symposium and published in The New England Journal of Medicine. HER2CLIMB investigated if adding tucatinib to a combination of trastuzumab and Xeloda, which is often used to treat patients with this particular type of ca
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