Vanflyta: which tox species, and why?

“Repeat-dose toxicology studies were conducted in Sprague-Dawley rats, beagle dogs, and cynomolgus monkeys given quizartinib dihydrochloride for up to 13 weeks.”

“Based on pharmacokinetic (PK) and toxicology data, the cynomolgus monkey was selected as a potential alternate nonrodent model for evaluating the toxicity profile of quizartinib to predict human safety risk.”

“Repeat-dose toxicology studies were conducted in Sprague-Dawley rats, beagle dogs, and cynomolgus monkeys given quizartinib dihydrochloride for up to 13 weeks.”

“Repeat-dose toxicology studies were conducted in Sprague-Dawley rats, beagle dogs, and cynomolgus monkeys given quizartinib dihydrochloride for up to 13 weeks.”

“In an embryo-fetal development (EFD) study in rats, quizartinib at doses resulting in exposures approximately 3 times the exposure at the maximum recommended human dose (MRHD) was associated with adverse developmental outcomes including structural abnormalities (anasarca and edema) and alterations to growth (lower fetal weights and effects on skeletal ossification).”

“No carcinogenicity studies were conducted or are required to support the marketing of quizartinib for the current indication.”

“Repeat-dose toxicology studies were conducted in Sprague-Dawley rats, beagle dogs, and cynomolgus monkeys given quizartinib dihydrochloride for up to 13 weeks.”