The U.S. Food and Drug Administration 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.
This is the first Project Orbis partnership between the FDA, HSA and Swissmedic. Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval. With a framework for concurrent submission and review of oncology drugs, Project Orbis facilitates a collaborative review to identify any regulatory divergence across review teams.
Tukysa is a kinase inhibitor meaning it blocks a type of enzyme (kinase) and helps prevent the cancer cells from growing. Tukysa is approved for treatment after patients have taken one or more anti-HER2-based regimens in the metastatic setting...
For more information about partnership at GMPnews.Net