Adcetris
brentuximab vedotin · CD3026 weeks
Zynlonta: how long were the pivotal tox studies?
loncastuximab tesirine · CD19
Longest pivotal study
13 weeks
“The Applicant conducted GLP 4‐week and 13‐week repeat‐dose general toxicology studies in which cynomolgus monkeys were dosed with the ADC, followed by a 12‐week recovery period.”
Pivotal GLP studies
GLP monkey 4-week (0.3, 0.6 mg/kg q3w) and 13-week (0.075-0.3 mg/kg q3w) IV, 12-week recovery; SG3199 4-week rat
“The Applicant conducted GLP 4‐week and 13‐week repeat‐dose general toxicology studies in which cynomolgus monkeys were dosed with the ADC, followed by a 12‐week recovery period.”
Route in tox
IV (30-minute infusion; clinical route)
“All in vivo studies with ADCT-402 or SG3199 used the IV route of administration, the intended clinical route of administration”
Same question, other ADCs
Besponsa
inotuzumab ozogamicin · CD2226 weeks
Datroway
datopotamab deruxtecan · Trop-213 weeks
Decnupaz
pivekimab sunirine · CD12313 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