FDA Approves Ivosidenib for Advanced/Metastatic Cholangiocarcinoma

The FDA has granted approval to ivosidenib (Tibsovo®, Servier Pharmaceuticals) for patients with previously treated, locally advanced, or metastatic cholangiocarcinoma that has an isocitrate dehydrogenase-1 (IDH1) mutation. In addition, the FDA approved the Oncomine™ Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to determine eligibility for treatment with ivosidenib. "Isocitrate dehydrogenase 1 (IDH1) mutations occur in approximately 13% of patients with intrahe...
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Pemigatinib for Cholangiocarcinoma: An Interview With Ghassan Abou-Alfa, MD, MBA

Fibroblast growth factor receptor (FGFR) 2 gene alterations can occur in the pathogenesis of cholangiocarcinoma. Pemigatinib (PemazyreTM, Incyte Corporation), a newly FDA approved oral inhibitor of FGFR2, has shown efficacy in patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with and without FGFR2 gene alterations. Approval was granted based a study led by Ghassan Abou-Alfa, MD, MBA from Memorial Sloan Kettering Cancer Center. In an interview with i3 Health, D...
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Pemigatinib Approved for Cholangiocarcinoma

Often, fibroblast growth factor receptor (FGFR) 2 gene alterations occur in the pathogenesis of cholangiocarcinoma. The FDA recently approved an oral inhibitor of FGFR2, pemigatinib (PemazyreTM, Incyte Corporation), which has shown efficacy in patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with and without FGFR2 gene alterations. FoundationOne®CDx was also approved as a companion diagnostic test for this indication.  FDA approval was based on a cli...
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