Seattle Genetics gets another Tukysa approval under Project Orbis

US biotech Seattle Genetics (Nasdaq: SGEN) says that Australian regulatory authorities have approved marketing of Tukysa (tucatinib) in combination with trastuzumab and capecitabine.

Tukysa is cleared for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

Australia joins the USA, Switzerland, Canada and Singapore that approved Tukysa under Project Orbis, an initiative of the US Food and Drug Administration Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international regulatory agencies.