Incyte's Pemazyre Wins Conditional Approval For Bile Duct Cancer In Canada

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  • Health Canada has given conditional approval to Incyte Corporation's INCY Pemazyre (pemigatinib) to treat cholangiocarcinoma.
  • Cholangiocarcinoma is a type of cancer that forms in the slender tubes (bile ducts) that carry the digestive fluid bile.
  • The approval covers adults with previously treated, unresectable locally advanced, or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
  • Pemazyre is a selective fibroblast growth factor receptor (FGFR) inhibitor.
  • The conditional approval is based on FIGHT-202 study data that resulted in an overall response rate (ORR) of 35.5% and a median duration of response of 9.1 months.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: INCY stock is up 1.24% at $76.93 during the market session on the last check Monday.
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