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These highlights do not include all the information needed to use LYTGOBI safely and effectively. See full prescribing information for LYTGOBI. LYTGOBI® (futibatinib) tablets, for oral use Initial U.S. Approval: 2022
Medication labelWhy this: Advisory · dailymed-prescription
LYTGOBI 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 [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- generic_name
- futibatinib
- brand_name
- LYTGOBI
- product_names
- FUTIBATINIB, LYTGOBI, futibatinib
- ndc
- 64842-0120, 64842-0120-6, 64842-0120-5, 64842-0120-4, 64842-0127, 64842-0127-7, 64842-0128, 64842-0128-8
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en