Adcetris
brentuximab vedotin · CD3026 weeks
Decnupaz: how long were the pivotal tox studies?
pivekimab sunirine · CD123
Longest pivotal study
13 weeks
“Groups of monkeys received 0, 0.01, 0.03, 0.1 mg/kg intravenous doses once every 21 days for 13 weeks.”
Pivotal GLP studies
GLP IV cyno single-dose (0.1-0.6 mg/kg, 28-day recovery) and 13-week Q3W (0.01-0.1 mg/kg, 8-week recovery); FGN849 rat studies
“The toxicity of PVEK has been characterized in single- and repeat-dose studies (up to 13 weeks in duration).”
Route in tox
IV (10-minute infusion single-dose; bolus in 13-week study)
“Dosing Route IV Infusion (10 minutes)”
Same question, other ADCs
Besponsa
inotuzumab ozogamicin · CD2226 weeks
Datroway
datopotamab deruxtecan · Trop-213 weeks
Elahere
mirvetuximab soravtansine · FRα10 weeks
Emrelis
telisotuzumab vedotin · c-Met13 weeks
Enhertu
fam-trastuzumab deruxtecan · HER213 weeks
Kadcyla
ado-trastuzumab emtansine · HER226 weeks
Mylotarg
gemtuzumab ozogamicin · CD3312 weeks
Padcev
enfortumab vedotin · Nectin-413 weeks
Polivy
polatuzumab vedotin · CD79b10 weeks
Tivdak
tisotumab vedotin · Tissue factor13 weeks
Trodelvy
sacituzumab govitecan · Trop-213 weeks
Zynlonta
loncastuximab tesirine · CD1913 weeks