Hyrnuo: which tox species, and why?

“The toxicity, the reversibility of effects, and exposures of sevabertinib were assessed in repeat dose, toxicology studies, up to 13 weeks duration in rats and monkeys.”

“Rats and cynomolgus monkeys were used in the toxicology program; both species are considered to be pharmacologically active and have a metabolism of sevabertinib comparable to that of humans. Dogs could not be used because of insufficient exposure due to enzyme induction after repeated dosing.”

“The toxicity, the reversibility of effects, and exposures of sevabertinib were assessed in repeat dose, toxicology studies, up to 13 weeks duration in rats and monkeys.”

“The Applicant evaluated the safety of sevabertinib administered orally once daily in 4- and 13- week good laboratory practice (GLP)-compliant general toxicology studies using rats and cynomolgus monkeys.”

“The Applicant conducted GLP-compliant embryo-fetal development (EFD) studies in pregnant rats to assess the effect of sevabertinib on embryonic and fetal development.”

“Carcinogenicity studies were not conducted for sevabertinib and are not warranted for the proposed indication.”

“Rats and cynomolgus monkeys were used in the toxicology program; both species are considered to be pharmacologically active and have a metabolism of sevabertinib comparable to that of humans.”