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 Therapeutic Goods Administration_Product
TGA approval of a targeted therapy heralds an era of precision medicine in this rare cancer.

New treatment for rare cancer cholangiocarcinoma approved in Australia

Therapeutic Goods Administration (TGA) "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)." 1

By AP News
Published - Sep 15, 2022, 12:38 PM ET
Last Updated - Mar 14, 2024, 05:36 AM EDT
  • Available to treat adults with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement
  • PEMAZYRE® (pemigatinib) is available via a co-pay access program in Australia
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