> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Lytgobi Web Page False, Misleading: FDA
- URL: https://www.fdaweb.com/lytgobi-web-page-false-misleading-fda/
- Published: 2025-03-26T12:00:00.000Z
- Updated: 2026-09-14T14:56:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158897

The CDER Office of Prescription Drug Promotion (OPDP) says its review of the “Efficacy Results” Web page for Taiho Oncology’s Lytgobi (futibatinib) tablets found it makes false and misleading representations about the drug’s benefits. A 3/21 [Notice of Violation](file:///C:/Users/James/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/3DM2SRK8/FDA%20has%20updated%20with%202024%20information%20the%20Web%20page%20it%20maintains%20on%20issues%20with%20the%20withdrawn%20Bayer%20Essure%20implanted%20birth%20control%20device.%20FDA%20says%20it%20received%20803%20medical%20device%20reports%20on%20Essure%20in%202024,%20significantly%20lower%20than%20the%203,626%20reports%20received%20in%202023.%20It%20was%20the%20lowest%20number%20of%20annual%20medical%20device%20reports%20on%20the%20device%20since%20it%20was%20withdrawn%20in%202019.) says the violations are particularly concerning because the promotional communication makes misleading representations about the efficacy of Lytgobi in patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements.

The notice says Lytgobi is indicated to treat adults with this condition and was approved under the accelerated approval pathway, with labeled Warnings and Precautions about ocular toxicity hyperphosphatemia and soft tissue mineralization, and embryo-fetal toxicity.

The notice says Taiho appears to be promoting Lytgobi using misleading claims and presentations that were addressed by OPDP in 12/7/2022 advisory comments. It says the efficacy claims are based on a single-arm study that cannot be interpreted as Taiho interprets it. “The disclosures of the study’s limitations in this promotional communication do not correct or mitigate the misleading representations or suggestions of the presentation,” the notice says.

Taiho was told to respond with a list of all Lytgobi promotional materials with similar presentations and its plan for the timely discontinuation of such communications, or for ceasing distribution of Lytgobi.