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PEMAZYRE (Specialised Therapeutics Alim Pty Ltd)
Product name
PEMAZYRE
Date registered
Evaluation commenced
Decision date
Approval time
194 (255 working days)
Active ingredients
pemigatinib
Registration type
NCE/NBE
Indication
Pemigatinib has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).
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.