Tukysa Combo Approved in Australia for Advanced HER2-Positive Breast Cancer

Tukysa Combo Approved in Australia for Advanced HER2-Positive Breast Cancer
The Australian Therapeutic Goods Administration (TGA) has approved Seattle Genetics' Tukysa (tucatinib), when given alongside trastuzumab and Xeloda (capecitabine), for the treatment of patients with advanced inoperable or metastatic HER2-positive breast cancer, who received at least one anti-HER2-based treatment for metastatic disease. The approval also includes those in whom cancer has already spread to the brain (brain metastases). With this approval, Australia joins the list of countries, including the U.S., Canada, Switzerland, and Singapore, where Tukysa has been approved for the same indication under Project Orbis. Project Orbis was created by the U.S. Food and Drug Administration's Oncology Center of Excellence to allow simultaneous submission and review of cancer medications among international regulatory partners. “The rapid approval of concurrent global reviews under FDA’s Pr
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