Imdelltra: how long were the pivotal tox studies?

“No adverse effects on any toxicology or safety pharmacology parameters evaluated at up to the high dose of 4500 µg/kg weekly for 3 months.”

“The nonclinical safety assessment of tarlatamab was based on a 10-day exploratory as well as 28-day GLP and 3-month GLP repeat-dose IV toxicology studies with once weekly doses of up to 4500 µg/kg.”

“The IV route of administration was chosen for in vivo nonclinical studies based on the intended clinical route of administration.”