Article
FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation.
Clinical cancer research : an official journal of the American Association for Cancer Research - 1 Jul 2022
Casak Sandra J, Pradhan Shan, Fashoyin-Aje Lola A, Ren Yi, Shen Yuan-Li, Xu Yuan, Chow Edwin Chiu Yuen, Xiong Ye, Zirklelbach Jeanne Fourie, Liu Jiang, Charlab Rosane, Pierce William F, Fesenko Nataliya, Beaver Julia A, Pazdur Richard, Kluetz Paul G, Lemery Steven J
Abstract excerpt
On August 25, 2021, the FDA approved ivosidenib for the treatment of adult patients with unresectable locally advanced or metastatic hepatocellular isocitrate dehydrogenase 1 (IDH1) mutated cholangiocarcinoma (CCA) as detected by an FDA-approved test with disease progression after 1 to 2 prior lines of systemic therapy for advanced disease. The approval was based on data from Study AG120-C-005 (ClarIDHy), a...
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