Bizengri
zenocutuzumab · HER2 x HER313 weeks
Columvi: how long were the pivotal tox studies?
glofitamab · CD20 x CD3
Longest pivotal study
4 weeks
“Longer duration repeat-dose toxicology studies were not conducted due to the exposure-limiting development of anti-drug antibodies (ADA) in a short dose-range finding study (data not shown) and the 4-week repeat-dose study.”
Pivotal GLP studies
GLP cynomolgus 2-week IV (2 weekly doses) and 4-week IV/SC step-up (every other day) studies with recovery
“The Applicant conducted GLP studies in cynomolgus monkeys, including 2-week and 4-week repeat-dose toxicology studies, via the intravenous (IV) and subcutaneous (SC) routes.”
Route in tox
IV (slow bolus) and SC
“Route of administration: IV (slow bolus) injection and SC”
Same question, other bispecifics
Blincyto
blinatumomab · CD19 x CD313 weeks
Elrexfio
elranatamab · BCMA x CD313 weeks
Epkinly
epcoritamab · CD20 x CD35 weeks
Hemlibra
emicizumab · FIXa x FX26 weeks
Imdelltra
tarlatamab · DLL3 x CD313 weeks
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)0 (no in vivo tox study)
Korjuny
catumaxomab · EpCAM x CD30 (no in vivo tox study)
Lunsumio
mosunetuzumab · CD20 x CD326 weeks
Lynozyfic
linvoseltamab · BCMA x CD314 weeks
Ordspono
odronextamab · CD20 x CD316 weeks
Removab
catumaxomab · EpCAM x CD30 (no in vivo tox study)
Rybrevant
amivantamab · EGFR x MET13 weeks
Talvey
talquetamab · GPRC5D x CD34 weeks
Tecvayli
teclistamab · BCMA x CD35 weeks
Vabysmo
faricimab · VEGF-A x Ang-226 weeks
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)13 weeks