Posted by Michael Wonder on 17 Apr 2020
FDA approves first new drug under international collaboration, a treatment option for patients with HER2-positive metastatic breast cancer
17 April 2020 - Today, as part of Project Orbis, the U.S. FDA approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments.
The FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada, Health Sciences Authority (HSA, Singapore) and Swissmedic (SMC, Switzerland) on this review.
This is the first Project Orbis partnership between the FDA, HSA and Swissmedic. While the FDA approved Tukysa today, the application is still under review at the other agencies.
