Benzinga | Aug 12, 2020 08:02AM EDT

Seattle Genetics Announces TUKYSA Approved For All Countries Participating In FDA's Project Orbis Initiative

- Australia Joins U.S., Switzerland, Canada and Singapore in Approval of TUKYSA for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer -

Seattle Genetics, Inc. (NASDAQ:SGEN) today announced that Australian regulatory authorities have approved TUKYSA(r) (tucatinib) in combination with trastuzumab and capecitabine 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 U.S., Switzerland, Canada and Singapore that approved TUKYSA under Project Orbis, an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international regulatory agencies.

In April, TUKYSA became the first new medicine approved in the United States under Project Orbis, and its approval is currently under review in the European Union. TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,2

"The rapid approval of concurrent global reviews under FDA's Project Orbis for TUKYSA will allow for accelerated market entry of this new best-in-class treatment to HER2-positive breast cancer patients in need," said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. "As our company continues to expand globally, we look forward to bringing TUKYSA to patients around the world."

The approvals are based on results from the pivotal trial HER2CLIMB, a randomized (2:1), double-blind, placebo-controlled trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). The study results were published in The New England Journal of Medicine in December 2019. The company is pursuing a broad development strategy for TUKYSA in earlier stage HER2-positive breast cancer and other solid tumors.