DJ Agios Seeks FDA Expanded OK for Tibsovo in IDH1-Mutant Cholangiocarcinoma >AGIO
By Colin Kellaher
Agios Pharmaceuticals Inc. in Monday said it filed with the U.S. Food and Drug Administration for expanded use of Tibsovo in patients with previously treated isocitrate dehydrogenase 1, or IDH1, mutated cholangiocarcinoma.
The Cambridge, Mass., biopharmaceutical company said it also requested priority review for the application, which, if granted, could result in a six-month review process.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease.
Agios said IDH1 mutations occur in roughly 13% of cases of cholangiocarcinoma, a rare and aggressive cancer of the bile ducts, adding that there are no approved systemic therapies for IDH1-mutated cholangiocarcinoma.
The FDA previously approved Tibsovo for the treatment of acute myeloid leukemia with a susceptible IDH1 mutation.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 01, 2021 08:59 ET (13:59 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.