“Toxicology studies with up to 13 weeks of dosing were conducted in rats and dogs.”
✓ VerifiedFDA multi-discipline review, p. 33Source ↗
Why that species
Supported by in vitro metabolism and nonclinical PK data
“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.”
✓ VerifiedFDA multi-discipline review, p. 45Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“In the 13-week toxicology study in dogs, animals received revumenib doses of 12.5, 25, or 40 mg/kg/day.”
✓ VerifiedFDA multi-discipline review, p. 34Source ↗