Posted by Michael Wonder on 28 May 2021
FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma
28 May 2021 - Today, the FDA granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics), a kinase inhibitor for 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 FoundationOne CDx (Foundation Medicine) for selection of patients with FGFR2 fusion or other rearrangement as a companion diagnostic device for treatment with infigratinib.
