Posted by Michael Wonder on 02 Dec 2019
Innovent Biologics announces FDA acceptance of NDA for pemigatinib in patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements
1 December 2019 - Innovent Biologics today announced that the new drug application submitted by Incyte to the U.S. FDA for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements has been accepted for priority review by FDA.
The NDA submission is based on data from Incyte's FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma.
