Emrelis: how long were the pivotal tox studies?

“The Applicant evaluated the safety of telisotuzumab vedotin in GLP-compliant 4- and 13-week studies in cynomolgus monkeys with the intended IV route of administration.”

“In the 13-week GLP-compliant repeat-dose toxicology study in monkeys (Report No. R&D/18/0622, Study No. 2100-287), telisotuzumab vedotin was intravenously administered at doses of 0.5, 1.5, and 3 mg/kg every 2 weeks for a total of seven doses, followed by an 8-week recovery period.”

“Route of administration: Intravenous”