Jemperli: how long were the pivotal tox studies?

“The Applicant evaluated the safety of dostarlimab in cynomolgus monkeys in GLP‐compliant repeat‐dose toxicity studies of up to 13 weeks duration.”

“The single dose and repeat dose studies of 4- and 13-week duration were all performed with similar dose levels of dostarlimab (10, 30 and 100 mg/kg).”

“Route of administration: Intravenous (IV) infusion”