Under Priority Review status, FDA has accepted Incyte’s (NASDAQ:INCY) NDA for pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.
The PDUFA target action date is May 30, 2020.
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