Voranigo: which tox species, and why?

“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.”

“Rat and cynomolgus monkey were selected as standard species and due to their metabolite profiles to assess the safety profile of vorasidenib.”

“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 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.”

“Dedicated studies to assess vorasidenib-related effects on fertility and pre- and postnatal development were not conducted, as these evaluations are not required for the current indication. Effects were observed on reproductive organs in male and female rats during 28-day and 13-week repeat-dose toxicity studies. Embryo-fetal development (EFD) studies were conducted in gravid rats and rabbits.”

“Two post-marketing requirements (PMRs) to conduct carcinogenicity studies in mice and rats were communicated to the Applicant.”

“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.”