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

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

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  • 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

Click here to­ read full press release/ article | Ref: Businesswire | Image: Street Signals


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