Datroway: how long were the pivotal tox studies?

“Datopotamab deruxtecan was administered i.v. to cynomolgus monkeys at doses of 10, 30 or 80 mg/kg every three weeks on five occasions in a GLP-compliant 3-month toxicity study with a 2-month recovery period, no deaths or moribundity were noted up to 80 mg/kg.”

“Datopotamab deruxtecan was administered i.v. to cynomolgus monkeys at doses of 10, 30 or 80 mg/kg every three weeks on five occasions in a GLP-compliant 3-month toxicity study with a 2-month recovery period, no deaths or moribundity were noted up to 80 mg/kg.”

“In 3-month repeat-dose toxicology studies evaluating the safety of datopotamab deruxtecan administered intravenously, the intended route of administration, there were no mortalities at doses up to 200 mg/kg in rats or doses up to 80 mg/kg in monkeys.”