Sarclisa: how long were the pivotal tox studies?

“Because an appropriate species for preclinical safety testing could not be identified, toxicology studies with isatuximab were limited to a repeat-dose (once weekly for 3 weeks) toxicity study in cynomolgus monkeys (preceded by a small exploratory study)”

“The weekly repeated intravenous administration of isatuximab for 3 weeks to cynomolgus monkeys at doses of 20, 50 or 100 mg/kg/week resulted in no isatuximab-related findings in any parameters and in any groups.”

“Study title/ Study number: SAR650984 - Repeat-dose (once weekly for 3 weeks) intravenous (0.5-hour infusion) toxicity study in cynomolgus monkeys / TSK0154”