WASHINGTON (dpa-AFX) - Seattle Genetics, Inc. (SGEN) announced the Swiss Agency for Therapeutic Products has granted approval for TUKYSA tablets in combination with trastuzumab and capecitabine, for the treatment of patients with metastatic HER2-positive breast cancer. The application for TUKYSA approval was reviewed by Swissmedic as part of Project Orbis, an initiative of the U.S. FDA Oncology Center of Excellence.
On April 17, the FDA approved TUKYSA in the U.S. under the FDA's Real-Time Oncology Review pilot program, and represented the first new drug approved under Project Orbis.
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