Futibatinib: second EMA approval for FGFR inhibitor in cholangiocarcinoma.

ESMO Open

Toronto Centre for Liver Disease, Toronto General Hospital, University Health Network, Toronto, Canada; Medical Oncology, Margaret Cancer Centre, Toronto, Canada.

Published: December 2023

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10651450PMC
http://dx.doi.org/10.1016/j.esmoop.2023.102049DOI Listing

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What Is This Summary About?: This summary describes the results from a phase 2 study called FOENIXCCA2. The study evaluated treatment with futibatinib in people with a rare form of advanced bile duct cancer called intrahepatic cholangiocarcinoma (or iCCA), where the tumors have changes in the structure of a gene called FGFR2. These changes include FGFR2 gene fusions.

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Biliary tract cancers (BTCs) are rare tumours, most often diagnosed at an unresectable stage, associated with poor prognosis, with a 5-year survival rate not exceeding 10%. Only first- and second-line treatments are well codified with the combination of cisplatin-gemcitabine chemotherapy and immunotherapy followed by 5-FU and oxaliplatin chemotherapy, respectively. Many studies have shown that BTC, and more particularly intrahepatic cholangiocarcinoma (iCCA), have a high rate of targetable somatic alteration.

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Article Synopsis
  • - The text discusses the current treatment landscape for cholangiocarcinoma (CCA), emphasizing that many patients are not surgical candidates and survival with traditional chemotherapy is under 12 months.
  • - A systematic review identified four FDA-approved targeted therapies for advanced CCA, including ivosidenib and three FGFR2 inhibitors, which have created new options for treatment and improved patient outcomes.
  • - The emergence of these targeted therapies has prompted new research into combination treatments, such as integrating chemotherapy and immunotherapy, enhancing the overall approach to managing CCA.
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