Revuforj: which tox species, and why?

“Toxicology studies with up to 13 weeks of dosing were conducted in rats and dogs.”

“The use of the rat and dog as the rodent and non-rodent species for the pivotal repeat-dose toxicity studies of revumenib is supported by the in vitro metabolism and nonclinical PK data observed.”

“In the 13-week toxicology study in dogs, animals received revumenib doses of 12.5, 25, or 40 mg/kg/day.”

“Toxicology studies with up to 13 weeks of dosing were conducted in rats and dogs.”

“Fertility and early embryonic development: As discussed in ICH S9, studies to evaluate the potential effects of revumenib on fertility and early embryonic development were not warranted and therefore not performed.”

“The FDA concurs. Carcinogenicity studies were not warranted for the proposed indication.”

“In the 13-week toxicology study in dogs, animals received revumenib doses of 12.5, 25, or 40 mg/kg/day.”