Polivy: how long were the pivotal tox studies?

“Cardiovascular, respiratory, and neurologic assessments were included in the 10-week repeat-dose toxicology study in cynomolgus monkeys, using polatuzumab vedotin or the surrogate ADC (10-0044).”

“In Cynomolgus monkeys, IV doses of 1, 3, and 5 mg/kg polatuzumab vedotin or 3 and 5 mg/kg of the surrogate ADC were administered Q3W for a total of 4 doses, followed by a 9-week recovery period.”

“In the repeat-dose rat study, polatuzumab vedotin was administered by intravenous (IV) injection once weekly for 4 weeks at doses of 2, 6, and 10 mg/kg.”