Adcetris
brentuximab vedotin · CD3026 weeks
Elahere: how long were the pivotal tox studies?
mirvetuximab soravtansine · FRα
Longest pivotal study
10 weeks
“A 10-week GLP compliant repeat-dose toxicity study with mirvetuximab soravtansine was conducted in cynomolgus monkey using the clinical IV route of administration”
Pivotal GLP studies
10-week GLP monkey (2, 4, 8 mg/kg q3w IV, 5-week recovery); single-dose monkey; GLP rabbit ocular 4-week weekly and 12-week q3w
“IMGN853 at doses of 0, 2, 4, and 8 mg/kg/dose was administered intravenously (slow push) to cynomolgus monkeys once every 3 weeks for up to 10 weeks (a total of 4 doses) with a 5- week recovery period (n=6/sex/group).”
Route in tox
IV (slow push in monkey; infusion in rabbit), clinical route
“A 10-week GLP compliant repeat-dose toxicity study with mirvetuximab soravtansine was conducted in cynomolgus monkey using the clinical IV route of administration”
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