TIBSOVO (Servier Laboratories (Aust) Pty Ltd)
Product name
TIBSOVO
Date registered
Evaluation commenced
Decision date
Approval time
136 (255 working days)
Active ingredients
ivosidenib
Registration type
NCE/NBE
Indication
TIBSOVO is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) R132 mutation after at least one prior line of systemic therapy.
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.