Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats previously treated, unresectable, locally advanced or metastatic intrahepatic…. Sold as Lytgobi. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Futibatinib (sold as Lytgobi), first approved Sep 30, 2022, with 0 new uses approved and 0 published complete response letters.
First approved: Sep 30, 2022
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $29.0M
Orphan exclusivity until: Sep 30, 2029
First approved in the EU: Jul 4, 2023
First approved in Japan: Jun 26, 2023
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 9 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Lytgobi tablets, new ingredientA drug with a new active ingredient indicated for the treatment of unresectable FGFR2 fusion gene-positive biliary tract cancer that has progressed after… · Taiho Pharmaceutical Co., Ltd. · Jun 26, 2023 · Review report
Clinical Trials
14 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
