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.
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.
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.
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.