FDA Approves Pemigatinib for Certain Unresectable Advanced Cholangiocarcinomas

On April 17, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

The FDA also approved the FoundationOne^® CDX (Foundation Medicine, Inc.)  as a companion diagnostic for patient selection.

Read FDA announcement.

Posted 4/20/2020