Voranigo: how long were the pivotal tox studies?

“The Applicant evaluated the safety of vorasidenib administered orally once daily in 28-day and 13-week GLP-compliant general toxicology studies using Sprague Dawley rats and cynomolgus monkeys.”

“The safety evaluation included 28-day and 13-week repeat-dose toxicity studies in Sprague-Dawley rats and cynomolgus monkeys”

“The non-clinical toxicity studies were conducted via oral gavage in rats and monkeys as the intended route of administration in patients.”