Adcetris
brentuximab vedotin · CD3026 weeks
Padcev: how long were the pivotal tox studies?
enfortumab vedotin · Nectin-4
Longest pivotal study
13 weeks
“No mortalities were reported in the 13-week study in rats administered enfortumab vedotin at doses up to 5 mg/kg once weekly (at 0.94-fold the exposure in human at the clinical recommended dose).”
Pivotal GLP studies
Weekly IV GLP: rat 4- and 13-week; monkey 4-week (ADC, naked Ab, MMAE); monkey bridging; rat 4-week testicular study
“The Applicant conducted GLP intravenous repeat-dose (weekly) general toxicology studies in rats (4 and 13-week) with enfortumab vedotin, and the unconjugated antibody (AGS-22M6)”
Route in tox
IV (weekly)
“The Applicant conducted GLP intravenous repeat-dose (weekly) general toxicology studies in rats (4 and 13-week) with enfortumab vedotin, and the unconjugated antibody (AGS-22M6)”
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
Polivy
polatuzumab vedotin · CD79b10 weeks
Tivdak
tisotumab vedotin · Tissue factor13 weeks
Trodelvy
sacituzumab govitecan · Trop-213 weeks
Zynlonta
loncastuximab tesirine · CD1913 weeks