Incyte Receive Positive CHMP’s Opinion for Pemigatinib

Shots:

  • The EMA’s CHMP has adopted a positive opinion of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status, after at least one line of ST
  • The CHMP opinion is based on P-II FIGHT-202 and patients enrolled into one of three cohorts – cohort a (FGFR2 fusions or rearrangements), cohort b (other FGF/FGFR genetic alterations) or cohort c (no FGF/FGFR genetic alterations)
  • Pemigatinib will be the 1st targeted therapy indicated in the EU if approved for this indication

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