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Tepmetko
Published
Product name
Tepmetko
Active ingredient
Tepotinib (as hydrochloride monohydrate)
Submission type
New chemical entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Tepmetko (tepotinib) was approved for the following therapeutic use:
Tepmetko has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).
How this medicine works
Tepotinib is a Type I adenosine triphosphate (ATP)- competitive small molecule inhibitor of mesenchymal-epithelial transition (MET). Tepotinib inhibits hepatocyte growth factor (HGF) dependent and independent MET phosphorylation and MET dependent downstream signalling including the phosphatidylinositol 3 kinase/protein kinase B and mitogen activated protein kinase/extracellular signal regulated kinase pathways in a dose dependent manner.
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 Tepmetko was considered favourable for the therapeutic use approved.
Sponsor