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TUKYSA (AA-Med Pty Ltd)
Product name
TUKYSA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
113 working days (255)
Active ingredients
tucatinib
Registration type
NCE/NBE
Indication
TUKYSA (film coated tablet) is indicated in combination with trastuzumab and capecitabine for treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available