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TUKYSA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
TUKYSA
Date registered
Evaluation commenced
Decision date
Approval time
208 (255 working days)
Active ingredients
tucatinib
Registration type
EOI
Indication
TUKYSA is indicated in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2 positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy. This indication was approved via the provisional approval pathway based on confirmed objective response rate (cORR) in a single arm trial. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration