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FDA's Orphan Drug Designation to ARQ 087 for Cholangiocarcinoma

doi: 10.1097/01.COT.0000480918.40956.66
FDA Updates


The U.S. Food and Drug Administration has granted orphan drug designation to ARQ 087 for the treatment of patients with cholangiocarcinoma. ARQ 087 is a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth receptor (FGFR) family.

A Phase II trial for ARQ 087 is currently ongoing in the U.S. and in Italy in a group of patients with intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions, according to the drug's developer, ArQule, Inc. The drug company is also continuing to enroll patients in the Phase IB portion of the trial with ARQ 087 in patients with solid tumors harboring the FGFR2 genetic alterations.

Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
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