Incyte’s Pemazyre (pemigatinib) Receives the US FDA’s Approval as the Novel Treatment for Adults with Previously Treated, Unresectable LA or Metastatic Cholangiocarcinoma

 Incyte’s Pemazyre (pemigatinib) Receives the US FDA’s Approval as the Novel Treatment for Adults with Previously Treated, Unresectable LA or Metastatic Cholangiocarcinoma

Incyte Reports Updated Results of Pemigatinib in P-II FIGHT-202 Trial for Patients with Previously Treated Advanced Cholangiocarcinoma

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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Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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