The Lynx Group
Cholangiocarcinoma News

FDA Approvals, News & Updates

Web Exclusives — August 30, 2021
Ivosidenib has been approved by the FDA for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test.
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June/July 2021, Vol 2, No 2 — July 28, 2021
The FDA granted accelerated approval to the kinase inhibitor infigratinib (Truseltiq) for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma (CCA) that harbors an FGFR2 fusion or other rearrangement.
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August 2020, Vol 1, No 1 — September 10, 2020
On June 2, 2020, the US Food and Drug Administration (FDA) granted an orphan drug designation to RenovoCath, an intra-arterial delivery device of gemcitabine (Gemzar) for the treatment of patients with cholangiocarcinoma (CCA). RenovoCath is developed by RenovoRx, a medical devices developer based in Los Altos, CA.
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