Incyte has secured Priority Review in the US for its New Drug Application (NDA) for pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for patients with cholangiocarcinoma, a rare cancer that forms in the bile duct.
The NDA submission is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma.
Study results demonstrated that in patients harbouring FGFR2 fusions or rearrangements, pemigatinib monotherapy resulted in an overall response rate of 36% (primary endpoint), and median duration of response of 7.5 months (secondary endpoint) with a median follow-up of 15 months.
Adverse events were manageable and consistent with the mechanism of action of pemigatinib, Incyte said.
The Prescription Drug User Fee Act (PDUFA) target action date for pemigatinib is May 30, 2020.