Shots:

• The approval is based on P-II FIGHT-202 (NCT02924376) study which involves assessing of Pemazyre (13.5 mg- qd) in adults with previously treated- locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement
• The study has three cohorts: Cohort A (FGFR2 fusions or rearrangements)- Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations and resulted in OR 36%- mDOR 9.1 mos.
• Pemazyre is an oral inhibitor of FGFR isoforms 1- 2 and 3 and has also received the US FDA’s BT Designation and ODD to treat patients with previously treated advanced/metastatic or unresectable FGFR2 translocated cholangiocarcinoma and for cholangiocarcinoma respectively

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