Tazverik: how long were the pivotal tox studies?

“To assess the safety of tazemetostat, Epizyme conducted GLP-compliant toxicology studies of up to 13-weeks in Sprague Dawley rats and cynomolgus monkeys.”

“Epizyme also conducted a GLP-compliant toxicology study of up to 13-weeks in juvenile Sprague Dawley rats starting from post-natal day (PND) 7 to 98.”

“In the 13-week monkey study, animals received oral tazemetostat at total daily doses of 100, 300, or 600 mg/kg/day (50, 150, 300 mg/kg BID).”