Summary

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• Lytgobi (futibatinib [tas-120]) is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
• This summary is based on the review of one randomized controlled trial(s). ^[1]
• The objective response rate (ORR) was 42% (43 out of 103 patients; 95% confidence interval, 32 to 52) among patients with unresectable or metastatic FGFR2 fusion-positive or FGFR2 rearrangement-positive intrahepatic cholangiocarcinoma.
• The median duration of response was 9.7 months, median progression-free survival (PFS) was 9.0 months, and median overall survival (OS) was 21.7 months in the studied population.
• Responses and effectiveness outcomes, including ORR and duration of response, were consistent across various patient subgroups, including those with heavily pretreated disease, older adults, and patients with co-occurring TP53 mutations.
• Common treatment-related Grade 3 adverse events included hyperphosphatemia (30%), increased AST levels (7%), stomatitis (6%), and fatigue (6%).
• Permanent discontinuation due to treatment-related adverse events occurred in 2% of patients, with no treatment-related deaths reported.
• There is no population types or subgroups information available in the reviewed studies.