Lytgobi: which tox species, and why?

“The Applicant conducted general toxicology studies in rats and dogs.”

“A similar metabolism was seen in rat, dog and human, such as O-demethylation, mono- or di-oxidation, hydration, and Phase II (cysteine or N-acetylcysteine conjugation) conversion.”

“Futibatinib was dosed orally daily or every‐other‐day in 4‐week and 13‐week GLP repeat‐dose studies.”

“The Applicant conducted general toxicology studies in rats and dogs.”

“In line with ICH S9, no fertility, PPND or juvenile animals studies were performed.”

“Carcinogenicity studies with futibatinib have not been conducted.”

“The Applicant conducted general toxicology studies in rats and dogs. Futibatinib was dosed orally daily or every‐other‐day in 4‐week and 13‐week GLP repeat‐dose studies.”