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Tukysa
Published
Product name
Tukysa
Active ingredient
Tucatinib
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Tukysa (tucatinib) was approved for the following therapeutic use:
Tukysa is indicated in combination with trastuzumab and capecitabine for 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.
How this medicine works
Tucatinib is a tyrosine kinase inhibitor of human epidermal growth factor receptor 2 (HER2). In vitro, tucatinib inhibits phosphorylation of HER2 and human epidermal growth factor receptor 3 (HER3), resulting in inhibition of downstream mitogen-activated protein kinase (MAPK) and AKT signalling and cell proliferation, and showed anti-tumour activity in HER2-expressing tumour cells. In vivo, tucatinib inhibited the growth of HER2-expressing tumours. The combination of tucatinib and trastuzumab showed increased anti-tumour activity in vitro and in vivo compared to either drug alone.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Tukysa was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- 328525, 328526
- 328525, 328526