Tukysa: how long were the pivotal tox studies?

“Twice daily oral administration of tucatinib was assessed in repeat-dose toxicity studies for up to 3 months in rats and monkeys, consistent with the clinical route of administration and intended dosing schedule.”

“Twice daily oral administration of tucatinib was assessed in repeat-dose toxicity studies for up to 3 months in rats and monkeys, consistent with the clinical route of administration and intended dosing schedule. The pivotal repeat-dose toxicology studies were conducted in compliance with Good Laboratory Practice regulations (21 CFR part 58).”

“Repeat dose studies were conducted in rats via oral gavage (Study 1140-028; GLP Study 8369684) and in monkeys via naso-gastric (Study JAY00093; GLP study) and oral gavage (Study 8369685; GLP study).”