US FDA Cites Taiho’s Lytgobi Healthcare Provider Website For Misleading Efficacy Claims

26 Mar 2025

Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.

Red flag — Taiho's healthcare provider website for Lytgobi raised some red flags for OPDP. (Shutterstock)

Key Takeaways

A healthcare provider webpage for Taiho’s Lytgobi misrepresented the cholangiocarcinoma drug’s efficacy, the FDA said.
The underlying single-arm study cannot support claims about progression-free survival, overall survival and disease cure rate, and disclaimers cannot cure the misleading representation, OPDP said in an "untitled" letter.
Taiho is the second company cited this year for running afoul of the CFL guidance, which provides guardrails for companies to promote data not included in product labeling.

A single-arm study cannot provide interpretable results supporting promotional claims for progression-free survival or overall survival, the US Food and Drug Administration said in an advertising and promotion violation letter...

The PFS, OS and disease control rate data presentation on Lytgobi’s healthcare provider website makes misleading representations about the drug’s efficacy in patients with intrahepatic cholangiocarcinoma, the Office of Prescription...

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