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

 ­ Ref: Incyte | Image: Incyte