Retevmo: how long were the pivotal tox studies?

“To assess the safety of selpercatinib, Loxo conducted GLP-compliant toxicology studies of up to 13-weeks in Sprague Dawley rats and Gottingen mini pigs.”

“Due to sex-specific differences in exposure, in the 13-week toxicology study male rats received selpercatinb at doses of 2, 7.5, or 20 mg/kg while females received 7.5, 25, or 75 mg/kg daily via oral gavage, followed by a 4-week recovery.”

“In a 13-week study in minipigs, male and female animals received selpercatinib at doses of 2, 5, or 15 mg/kg/day for 13 weeks via oral gavage.”