TRUSELTIQ (Adjutor Healthcare Pty Ltd)
Product name
TRUSELTIQ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
189 (255 working days)
Active ingredients
infigratinib
Registration type
NCE/NBE
Indication
Disease and setting
TRUSELTIQ (infigratinib) (capsule) has provisional approval in Australia for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement (see Section 4.2 Dose and method of administration). The decision to approve this indication has been made on the basis of overall 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.