FDA Approvals, News & Updates

FDA Grants TT-00420, a Multi-Kinase Inhibitor, Fast-Track Review for Cholangiocarcinoma

FDA Approvals, News & Updates, Cholangiocarcinoma

Web Exclusives — November 9, 2021

On November 3, 2021, TransThera Sciences announced that the FDA granted its investigational drug, TT-00420, a spectrum-selective multi-kinase inhibitor, a fast-track designation for the treatment of patients with cholangiocarcinoma (CCA) who have no available standard treatment options. In preclinical studies, TT-00420 has shown high activity in a variety of FGFR mutations.

Tibsovo First Targeted Therapy FDA Approved for Advanced or Metastatic CCA with IDH1 Mutation

FDA Approvals, News & Updates, Cholangiocarcinoma

September/October 2021, Vol 2, No 3 — October 7, 2021

On August 25, 2021, the FDA approved ivosidenib (Tibsovo; Servier Pharmaceuticals), an oral IDH1 inhibitor, for the treatment of adults with previously treated, locally advanced or metastatic cholangiocarcinoma (CCA) and an IDH1 mutation, as detected by an FDA-approved test. The FDA granted ivosidenib a priority review for this indication and an orphan drug designation.

Ivosidenib Approved for Advanced or Metastatic Cholangiocarcinoma

Cholangiocarcinoma, 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.

FDA Grants Accelerated Approval to Infigratinib for Metastatic Cholangiocarcinoma

Cholangiocarcinoma, Emerging Therapies, FDA Approvals, News & Updates

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.

FDA Grants Orphan Drug Designation to RenovoCath’s Delivery of Intra-Arterial Gemcitabine for the Treatment of Cholangiocarcinoma

FDA Approvals, News & Updates

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.

FDA Approvals, News & Updates

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