Incyte lining up pemigatinib filing on ESMO data

With updated data presented at ESMO, Incyte said it will submit an NDA to FDA this year to seek accelerated approval of its FGFR inhibitor in a niche cancer indication of cholangiocarcinoma. The biotech also has plans to expand the pemigatinib program to include a tissue-agnostic indication.

Incyte Corp. (NASDAQ:INCY) presented results from the Phase II, single-arm FIGHT-202 trial of pemigatinib in patients with previously treated, locally advanced or metastatic cholangiocarcinoma. On the final analysis of the primary endpoint, pemigatinib showed an overall response rate of 36% among 107 patients with FGFR2 fusions or rearrangements. There were no responses among patients with other FGFR alterations (n=20) or patients with no FGF or FGFR alterations (n=18)...