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# Taiho Oncology Bile Duct Cancer Drug OK’d
- URL: https://www.fdaweb.com/taiho-oncology-bile-duct-cancer-drug-okd/
- Published: 2022-10-03T12:00:00.000Z
- Updated: 2026-09-14T18:01:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152872

FDA has approved a Taiho Oncology NDA for Lytgobi (futibatinib) for treating adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic bile duct cancer (cholangiocarcinoma) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements, which is determined using next-generation sequencing.

Approval was based on efficacy data from TAS-120-101 (NCT02052778), a single-arm trial that enrolled 103 patients. The data showed an overall response rate (ORR) of 42% and duration of response was 9.7 months, according to an FDA [news release](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjA5MzAuNjQ1MDI4MjEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L2RydWdzL3Jlc291cmNlcy1pbmZvcm1hdGlvbi1hcHByb3ZlZC1kcnVncy9mZGEtZ3JhbnRzLWFjY2VsZXJhdGVkLWFwcHJvdmFsLWZ1dGliYXRpbmliLWNob2xhbmdpb2NhcmNpbm9tYT91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkifQ.JE7CHU3UsY2zIiTpKMuEdSydI6cKtlpndCOx6whZMJk/s/1255931999/br/145022430770-l?ref=fdaweb.com).

In terms of safety, the most common adverse reactions occurring in 20% or more of patients were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting, the agency says.