Ojemda: which tox species, and why?

“Sprague Dawley rats and cynomolgus monkeys were used as relevant species based on comparison of metabolite profiles generated by isolated hepatocytes from mice, rats, dogs, rabbits, cynomolgus monkeys, and humans.”

“Sprague Dawley rats and cynomolgus monkeys were used as relevant species based on comparison of metabolite profiles generated by isolated hepatocytes from mice, rats, dogs, rabbits, cynomolgus monkeys, and humans.”

“In the 3-month study in monkeys, tovorafenib was administered in a Q2D schedule with doses up to 20 mg/kg/day.”

“Sprague Dawley rats and cynomolgus monkeys were used as relevant species based on comparison of metabolite profiles generated by isolated hepatocytes from mice, rats, dogs, rabbits, cynomolgus monkeys, and humans.”

“In consistency with reproductive toxicity findings in the FEED study, in the preliminary EFD study, administration of tovorafenib caused 100% early resorptions and total litter loss in all treated pregnant rats at doses of 37.5, 75, or 150 mg/kg/day.”

“The study report of 26-week Tg Ras mouse carcinogenicity study was submitted. In this study Tg Ras mice were dosed at 10, 30, and 100 mg/kg/day by oral gavage for 26 weeks.”

“In the 3-month study in monkeys, tovorafenib was administered in a Q2D schedule with doses up to 20 mg/kg/day.”