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”