Scemblix: which tox species, and why?

“The safety of asciminib was assessed in general toxicology (dogs, rats and monkeys up to 4, 26 and 39 weeks, respectively), genotoxicity (in vitro and in rats), and reproductive and developmental toxicology (rats and rabbits) studies.”

“Because there is a very high overall protein sequence conservation of ABL1 and ABL2 kinase domains across human and toxicology relevant species (mouse, rat, rabbit, dog, minipig, cynomolgus and rhesus monkeys)”

“Prolonged administration of asciminib (3, 15, and 50 mg/kg/day) for 39 weeks in cynomolgus monkeys induced comparable findings to those observed in the 13-week study”

“The safety of asciminib was assessed in general toxicology (dogs, rats and monkeys up to 4, 26 and 39 weeks, respectively), genotoxicity (in vitro and in rats), and reproductive and developmental toxicology (rats and rabbits) studies.”

“The potential for reproductive and/or developmental toxicity of asciminib was investigated in a study on fertility and early embryonic development in the rat and studies on embryo-foetal development in rats and rabbits.”

“In a 2-year carcinogenicity study, rats were administered oral doses of asciminib at 20, 66, and 200 mg/kg/day in males and 10, 30, and 66 mg/kg/day in females.”

“The safety of asciminib was assessed in general toxicology (dogs, rats and monkeys up to 4, 26 and 39 weeks, respectively), genotoxicity (in vitro and in rats), and reproductive and developmental toxicology (rats and rabbits) studies.”