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QINLOCK (Tudorrose Consulting Pty Ltd)

Product name
Date registered
Evaluation commenced
Decision date
Approval time
123 working days (255)
Active ingredients
Registration type

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.

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