Enhertu: how long were the pivotal tox studies?

“In cynomolgus monkeys, Cmax and AUC0-21d values increased dose-dependently, and there were no accumulation or sex-related differences in toxicokinetic parameters following administration of 3, 10, or 30 mg/kg DS-8201a IV, once every 3 weeks for 3 months.”

“The Applicant conducted GLP-compliant, repeat-dose general toxicology studies to evaluate the toxicity of DS-8201a, MAAA-1181a, or MAAL-9001 in rats and/or monkeys.”

“The in vivo studies were primarily conducted via intravenous injection in mice, rats, and monkeys, as this is the intended route of administration in humans.”