Tukysa Approved as Combo Therapy for Metastatic HER2-positive Breast Cancer in Switzerland

Tukysa Approved as Combo Therapy for Metastatic HER2-positive Breast Cancer in Switzerland
The Swiss Agency for Therapeutic Products (Swissmedic) has approved Seattle Genetics' Tukysa, in combination with trastuzumab and Xeloda (capecitabine), for the treatment of patients with metastatic HER2-positive breast cancer. Tukysa is now approved for individuals who have been treated previously with at least two other anti-HER2 therapies, examples of which include Kadcycla (ado-trastuzumab emtansine), Perjeta (pertuzumab), and trastuzumab (sold under the brand name Herceptin, among others). Swissmedic reviewed the Tukysa application as part of Project Orbis. This initiative, from the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, gives a framework for simultaneous submission and review of cancer-treating medications among multiple international regulatory agencies. In addition to the U.S. and Switzerland, this includes agencies from Canada, Australia, and Singapore. The FDA approved Tukysa in April, making it the first medication to be approved under Project Orbis. The Swissmedic approval represents the first regulatory approval for Tukysa outside the U.S., and the first Swiss approval under Project Orbis. "We’re grateful to Swissmedic for their collaboration through FDA’s Project Orbis in approving this important new medicine in Switzerland," Jennifer Stephens, vice president of regulatory affairs at Seattle Genetics, said in a press release. "We're committed to bringing new targeted therapies to patients, and we are excited about this important first step toward making Tukysa available to patients in Switzerland." HER2 is a protein that drives the growth of certain breast cancers (which are dubbed "HER2-positive"). Tukysa blocks the activity of this protein. Tukysa is able to penetrate the blood-brain barrier.
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