Biliary Tract Cancer

New Drug: Futibatinib for Cholangicarcinoma

2023-01-10

  • Study

    A single-arm, multicenter, phase 2 study
    Advanced/metastatic unresectable iCCA harboring FGFR2 gene fusions
    Disease progression after ≥1 line of systemic therapy
    Futibatinib 20 mg QD until disease progression/unacceptable toxicity ( n=103)


  • Efficacy

    ORR: 42 % [32.0-52.0]
    mDoR: 9.7 mos [7.6-17.1 mos]


  • Safety

    Any grade AEs: hyperphosphatemia (79.1%), diarrhea (37.3%), dry mouth (32.8%)
    Grade ≥3 AEs: hyperphosphatemia (25.4%)
    Treatment related death: 2 patients


    • FDA package insert

    A phase II, open-label, multicenter study of futibatinib in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements.

    http://www.ncbi.nlm.nih.gov/pubmed/0

    Reviewed by Elvin Chalabiyev, MD on Jan 10, 2023