Incyte Reports Acceptance and Priority Review of NDA for Pemigatinib to Treat Patients with Cholangiocarcinoma

Incyte Reports Acceptance and Priority Review of NDA for Pemigatinib to Treat Patients with Cholangiocarcinoma

Shots:

  • The NDA submission is based on P-II FIGHT-202 study assessing Pemigatinib in patients aged ≥ 18yrs. with previously treated, LA/metastatic cholangiocarcinoma with documented FGF/FGFR status
  • The P-II FIGHT-202 study resulted in 36% ORR, 7.5mos. mDOR with a median follow-up of 15 mos. in patients harboring FGFR2 fusions or rearrangements. AEs are manageable and consistent with the MOA of Pemigatinib
  • Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 and has received FDA’s BT and ODD for the treatment of previously treated, advanced/metastatic or unresectable FGFR2 translocated cholangiocarcinoma

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