Empliciti: how long were the pivotal tox studies?

“Repeat-dose toxicity studies of elotuzumab were not conducted due to the lack of a relevant toxicology species or a valid transgenic mouse model.”

“A single dose of intravenously infused elotuzumab (0, 30, or 100 mg/kg) was well tolerated in rhesus monkeys with no clinical signs at any dose.”

“In this study, elotuzumab was administered via continuous IV infusion over 30 minutes to 3 groups of rhesus monkeys (1 monkey/sex/group) at doses of 0, 30, or 100 mg/kg.”