TUKYSA (tucatinib) has been approved in Australia for the treatment of metastasis HER2-positive breast cancer.

Seattle Genetics announced today that Australian regulators have approved TUKYSA® (tucatinib) to be used in the treatment of advanced non-removable or metastasis HER2-positive breast cancer patients, including those with brain metastasis.
Australia has joined the United States, Switzerland, Canada and Singapore in forming Project Orbis, an initiative of the U.S. Food and Drug Administration's Center of Excellence in Oncology to promote simultaneous review of anti-tumor drugs by international regulators.
, TUKYSA became the first new drug Obis plans to approve in the United States and is currently under review in the European Union.
Clay Siegall, Executive Director of Genetics, Seattle, said, "Orbis' planned global review of TUKYSA will bring this new treatment to market quickly, and we look forward to bringing TUKYSA to patients around the world."
the approval was based on the results of a key trial, HER2CLIMB (double-blind placebo-controlled trial), which recruited 612 patients who had previously been treated with treatments such as curto-bead monotherapy and parto-pearl monoantigen, respectively.
findings were published in the New England Journal of Medicine in December 2019.
TUKYSA is an oral drug that is a tyrosine kinase inhibitor of the HER2 protein.
in-body trials, TUKYSA inhibited phosphorylation of HER2 and HER3, thereby inhibiting downstream MAPK and AKT signaling and cell proliferation, and showing anti-tumor activity in tumor cells expressing HER2.
in vivo tests, TUKYSA inhibited the growth of HER2-positive tumors.
combination of TUKYSA and anti-HER2 antibody crater bead monoantigens showed enhanced anti-tumor activity both in vitro and in vivo.
in the United States, TUKYSA's combination with curtum monoantigen and carpedabin was approved for advanced non-excisive or metastasis adult patients with HER2-positive breast cancer, including those with brain metastasis.
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