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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