Inqovi: which tox species, and why?

“In the general toxicology studies, cedazuridine (mice and cynomolgus monkeys) and decitabine (rats) were administered orally once daily for 5 to 7 days in 28-day cycles, similar to the clinical regimen.”

“A literature assessment submitted by the Applicant concluded that humans, mice, and cynomolgus monkeys have similar CDA tissue distribution and activity profiles, and CDA activity was notably absent in rats.”

“Pivotal studies of oral decitabine monotherapy were limited to a 13-week/4-cycle study conducted in rats only (up to 7.5 mg/kg/dose).”