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TGA approved Tukysa for breast cancer in Australia

The Australian Therapeutic Good Administration has given a positive recommendation for Tukysa (tucatinib) for treating breast cancer. The drug is administered in combination with trastuzumab and capecitabine for patients suffering from advanced unresectable or metastatic HER2-positive breast cancer. The drug is indicated after treating with one or more anti-HER2 based regiments.

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Tucatinib is a tyrosine kinase inhibitor, acts by inhibiting the phosphorylation of HER2 and human epidermal growth factor receptor (HER3), which eventually leads to mitogen-activated protein kinase (MAPK) inhibition and SKT signaling and cell proliferation.

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AA-Med Pty Ltd is the sponsor of Tukysa in Australia.

The product has been approved in other countries, including the United States and Switzerland.

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Seattle Genetics has market authorization for the product in the United States. The approval in the US is based on a randomized, double-blind, placebo-controlled clinical trial that enrolled 612 patients. Progression-free survival was considered as the primary outcome. 7.8 was the median months in Tukysa + trastuzumab + capecitabine compared to 5.6 months in placebo + trastuzumab + capecitabine.

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