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Lytgobi FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 2, 2022.

FDA Approved: Yes (First approved September 30, 2022)
Brand name: Lytgobi
Generic name: futibatinib
Dosage form: Tablets
Company: Taiho Oncology, Inc.
Treatment for: Cholangiocarcinoma

Lytgobi (futibatinib) is an irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4 for the treatment of intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

Development timeline for Lytgobi

Sep 30, 2022Approval FDA Approves Lytgobi (futibatinib) for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma
Mar 30, 2022U.S. Food and Drug Administration (FDA) Accepts for Priority Review Taiho Oncology’s New Drug Application for Futibatinib for Cholangiocarcinoma

Further information

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