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Qinlock
Published
Product name
Qinlock
Active ingredient
Ripretinib
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Qinlock (ripretinib) was approved for the following therapeutic use:
Qinlock is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumours (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
How this medicine works
Ripretinib is a switch-control tyrosine kinase inhibitor with a dual mechanism of action. Ripretinib binds to both the switch pocket and the activation loop to lock the kinase in the inactive state, preventing downstream signalling and cell proliferation. This dual mechanism of action provides broad inhibition of KIT and platelet-derived growth factor receptor A (PDGFRA) kinase activity, including wild type and multiple primary and secondary mutations. Ripretinib also inhibits other kinases in vitro, such as platelet-derived growth factor receptor beta (PDGFRB), tunica interna endothelial cell kinase 2 (TIE2), vascular endothelial growth factor receptor-2 (VEGFR2), and BRAF.
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 Qinlock was considered favourable for the therapeutic use approved.
Sponsor
ARTG details