Zynyz: how long were the pivotal tox studies?

“The Applicant evaluated the toxicity of retifanlimab in a 13-week GLP-compliant repeat-dose toxicology study in cynomolgus monkeys.”

“Pivotal repeat-dose toxicity studies with retifanlimab in cynomolgus monkeys include a 4-week study (doses: 0, 10, 40, or 150 mg/kg) with a 10-week recovery period (T19-01-03) and a 13 week study (doses: 0, 5, 20, 100 mg/kg; T18 02-10).”

“In both studies, retifanlimab was administered once weekly by IV infusion (1 hour infusion in 4-week study, 30 minute infusion in 13-week study).”