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 for Taiho Oncology’s Lytgobi (futibatinib).
US FDA Cites Taiho’s Lytgobi Healthcare Provider Website For Misleading Efficacy Claims
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.
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