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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Bringing Precision Medicine to Cholangiocarcinoma With Mitesh J. Borad, MD

With an estimated incidence of 8,000 new cases per year, cholangiocarcinoma is a rare and aggressive tumor type that accounts for only 3% of all gastrointestinal cancers. Outcomes are poor, with 5-year survival rates ranging from 24% to as low as 2%. In this episode of Oncology Data Advisor, Mitesh J. Borad, MD, Associate Professor of Medicine and Director of the Liver and Biliary Cancer Research Program at the Mayo Clinic Cancer Center in Phoenix, Arizona, joins i3 Health for a discussion that ...
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Vivek Subbiah, MD, on Dabrafenib/Trametinib Efficacy in Biliary Tract Cancer

According to a recent study, led by Vivek Subbiah, MD, of The University of Texas MD Anderson Cancer Center, dabrafenib in combination with trametinib is an effective treatment option for patients with BRAFV600E -mutated biliary tract cancer (BTC). In an interview with i3 Health, Dr. Subbiah shares insights on the significance of these study results and unmet needs and future treatment in this patient population. What are the most challenging aspects of treating patients with BRAFV600E -mutated ...
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Dabrafenib/Trametinib Effective in Mutated Biliary Tract Cancer

Patients with biliary tract cancer often experience disease relapse after gemcitabine-based chemotherapy, representing an area of need in this patient population. In 5% of biliary tract tumors, a mutation in the BRAF gene is found. Dabrafenib in combination with trametinib has been shown to be an effective treatment option for patients with BRAFV600E – mutated cancers, particularly those with biliary tract cancer, according to a recent study, results of which were published in The Lancet Oncolog...
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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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