Incyte’s Pemazyre (pemigatinib) Receives MHLW’s Approval for Unresectable Biliary Tract Cancer with a FGFR2 Fusion Gene

March 24, 2021 Auto Bot approval, Incyte, MHLW, receives, regulatory, Treatment, Unresectable 0

Shots:

  • The approval is based on the P-II FIGHT-202 study that involves assessing Pemazyre (13.5mg, qd, on a 21-day cycle) in adults aged ≥18yrs. with previously treated, LA/m- cholangiocarcinoma with documented FGFR2 fusion or rearrangement
  • The study has three cohorts: Cohort A (FGFR2 fusions), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations and resulted in ORR (36%), mDOR (7.49mos.), TEAE grade ≤2 hyperphosphatemia of 58.2% in Cohort A
  • Pemazyre is a selective FGFR inhibitor for unresectable BTC with FGFR2 fusion gene1, worsening after cancer CT and has previously received the MHLW’s ODD

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