QINLOCK (Tudorrose Consulting Pty Ltd)
Product name
QINLOCK
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
123 working days (255)
Active ingredients
ripretinib
Registration type
NCE/NBE
Indication
QINLOCK (tablet) 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.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.