Romvimza: which tox species, and why?

“Repeat-dose toxicology studies were conducted in rats (4-weeks, 13-weeks, and 26-weeks) and dogs (4-weeks, 13-weeks, and 39-weeks).”

“Rats, rabbits, dogs, and mice were selected as relevant species in the toxicology studies based on high protein homology (up to 96%) of the pharmacologic target of vimseltinib.”

“GLP repeat-dose toxicity studies were conducted with vimseltinib in rats and dogs up to 26 and 39 weeks of duration, respectively.”

“Repeat-dose toxicology studies were conducted in rats (4-weeks, 13-weeks, and 26-weeks) and dogs (4-weeks, 13-weeks, and 39-weeks).”

“Developmental and reproductive toxicology studies comprised studies on male and female fertility and early embryonic development, in rats, embryo-foetal development, in rats and rabbits (only dose range study in the rabbit), and pre- and post-natal development, in rats.”

“In a 6-month transgenic mouse carcinogenicity study at doses up to 12.5 mg/kg/day, vimseltinib was negative for carcinogenic findings. The Applicant is currently conducting a 104-week carcinogenicity study in Sprague Dawley rats to be submitted as a PMR.”

“Repeat-dose toxicology studies were conducted in rats (4-weeks, 13-weeks, and 26-weeks) and dogs (4-weeks, 13-weeks, and 39-weeks).”