Cyramza: how long were the pivotal tox studies?

“The Applicant submitted 5-week and 39-week GLP-compliant toxicity studies in cynomolgus monkeys.”

“In the 5-week study, ramucirumab was administered by intravenous infusion on Days 1, 15, 22, and 29 at dose levels of 0, 4, 12, and 40 mg/kg. In the 39-week study, ramucirumab was administered by intravenous infusion weekly at dose levels of 0, 5, 16, and 50 mg/kg.”

“Ramucirumab was administered intravenously (i.v.) as either a slow bolus in the 5-week study, or an approximate 10 minute i.v. infusion in the 39-week study.”