FDA approves Tukysa + trastuzumab + capecitabine to treat unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases.- Seattle Genetics

Seattle Genetics, Inc. announced the FDA granted approval to Tukysa(tucatinib) tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable (cannot be surgically removed) or metastatic HER2-positive breast cancer, including patients with brain metastases (disease that has spread to the brain), who have received one or more prior anti-HER2-based regimens in the metastatic setting.

The FDA previously granted Breakthrough Therapy designation and Priority Review for Tukysa and reviewed this application for approval under the Real-Time Oncology Review (RTOR) pilot program. The Tukysa New Drug Application (NDA) is also part of Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international health authorities. Tukysa is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.