Xpovio: which tox species, and why?

“Rats were chosen as the rodent species and cynomolgus monkeys as the non-rodent species.”

“Based on available data, both species were determined to be pharmacologically relevant for toxicology studies.”

“Thirteen-week repeat-dose oral toxicity and toxicokinetic studies were conducted in the rat (0, 0.25, 1, or 4 mg/kg selinexor; 5 total doses given every 2-week period) and monkey (0, 0.1, 0.3, 1 mg/kg selinexor; 2 to 3 times/week) to support the NDA.”

“Thirteen-week repeat-dose oral toxicity and toxicokinetic studies were conducted in the rat (0, 0.25, 1, or 4 mg/kg selinexor; 5 total doses given every 2-week period) and monkey (0, 0.1, 0.3, 1 mg/kg selinexor; 2 to 3 times/week) to support the NDA.”

“No carcinogenicity study was conducted, and only maternal and embryo-foetal development toxicity were carried out, indicating a NOAEL value at 0.25 mg/Kg/day for rats. No data for a second species were provided.”

“Carcinogenicity studies were not conducted to support the use of selinexor for the proposed indication.”

“Based on available data, both species were determined to be pharmacologically relevant for toxicology studies.”