Tevimbra: how long were the pivotal tox studies?

“The Applicant performed a first repeat-dose toxicology study in monkeys (P14-057-CD), where 0/3/10/30 mg/kg tislelizumab was administered IV once biweekly for 13 weeks to 6 animals/sex/group followed by a 6-week recovery period”

“In repeat-dose toxicology studies in cynomolgus monkeys with intravenous dose administration for 13 weeks at doses of 3, 10, 30 or 60 mg/kg every 2 weeks for 13 weeks (7 dose administrations)”

“Doses of 0/30/60 mg/kg tislelizumab was administered IV once every two weeks for 13 weeks to 3 animals/sex/group or as two single doses (14 days apart to 3 males only) via subcutaneous injection (SQ).”