LYTGOBI (Taiho Pharma Oceania Pty Ltd)
Product name
LYTGOBI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
234 (255 working days)
Active ingredients
futibatinib
Registration type
NCE/ NBE
Indication
LYTGOBI monotherapy has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic intrahepatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of the favourable objective response rate and duration of response 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
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.