Kadcyla: how long were the pivotal tox studies?

“Therefore, long-term (e.g., 3- and 6-month) repeat-dose toxicology studies with ado-trastuzumab emtansine were conducted in monkeys.”

“The Applicant did a second multidose toxicology study in Cynomolgus monkeys (study 07-0653). The animals received doses of TDM1 of 0 1, 3, or 10 mg/kg once every three weeks for 8 doses.”

“T-DM1 is intended for IV administration, and therefore this route of administration was used in the non-clinical studies.”