Actemra
tocilizumab · IL-6R26 weeks
Margenza: how long were the pivotal tox studies?
margetuximab · HER2
Longest pivotal study
13 weeks
“Dose and frequency of dosing: 0, 15, 50, and 100 mg/kg/dose; once weekly for 13 consecutive weeks (13 doses)”
Pivotal GLP studies
GLP cynomolgus monkey 6-week (up to 150 mg/kg/dose) and 13-week (up to 100 mg/kg/dose) repeat-dose studies
“The Applicant conducted GLP-compliant 6-week (doses up to 150 mg/kg/dose) and 13-week (doses up to 100 mg/kg/dose) repeat-dose toxicology studies of margetuximab in cynomolgus monkeys.”
Route in tox
IV infusion (1 hour), once weekly
“Route of administration: IV infusion (1 hour)”
Same question, other monoclonal antibodies
Adakveo
crizanlizumab · P-selectin26 weeks
Adbry
tralokinumab · IL-1326 weeks
Aduhelm
aducanumab · Aggregated amyloid-β26 weeks
Aimovig
erenumab · CGRP receptor26 weeks
Ajovy
fremanezumab · CGRP26 weeks
Alhemo
concizumab · TFPI52 weeks
Andembry
garadacimab · Factor XIIa26 weeks
Anthim
obiltoxaximab · B. anthracis PA1 (dosing on Days 1, 4 and 7 in rats)
Arzerra
ofatumumab · CD2030 (7 months)
Avastin
bevacizumab · VEGF-A26 weeks
Bavencio
avelumab · PD-L113 weeks
Benlysta
belimumab · BLyS (BAFF)26 weeks
Beyfortus
nirsevimab · RSV F protein4 weeks
Bimzelx
bimekizumab · IL-17A/IL-17F26 weeks
Briumvi
ublituximab · CD2026 weeks
Cablivi
caplacizumab · von Willebrand factor (A1 domain)26 weeks
Campath
alemtuzumab · CD524 weeks
Cimzia
certolizumab pegol · TNF-α52 weeks
Cinqair
reslizumab · IL-526 weeks
Cosentyx
secukinumab · IL-17A26 weeks
Crysvita
burosumab · FGF2340 weeks
Cyramza
ramucirumab · VEGFR239 weeks
Danyelza
naxitamab · GD213 weeks
Darzalex
daratumumab · CD386 weeks
Dupixent
dupilumab · IL-4Ra26 weeks
Ebanga
ansuvimab · Zaire ebolavirus glycoprotein4 weeks
Ebglyss
lebrikizumab · IL-1339 weeks
Emgality
galcanezumab · CGRP26 weeks
Empliciti
elotuzumab · SLAMF70 (no repeat-dose toxicity studies)
Enflonsia
clesrovimab · RSV F protein (site IV)2 weeks
Enjaymo
sutimlimab · Complement C1s26 weeks
Enspryng
satralizumab · IL-6R26 weeks
Entyvio
vedolizumab · α4β7-integrin26 weeks
Erbitux
cetuximab · EGFR39 weeks
Evenity
romosozumab · Sclerostin26 weeks
Evkeeza
evinacumab · ANGPTL326 weeks
Exdensur
depemokimab · IL-526 weeks
Fasenra
benralizumab · IL-5Rα39 weeks
Gamifant
emapalumab · IFN-γ13 weeks
Gazyva
obinutuzumab · CD2026 weeks
Herceptin
trastuzumab · HER226 weeks
Humira
adalimumab · TNF-α39 weeks
Hympavzi
marstacimab · TFPI26 weeks
Ilaris
canakinumab · IL-1β26 weeks
Ilumya
tildrakizumab · IL-23 p1939 weeks
Imaavy
nipocalimab · FcRn26 weeks
Imfinzi
durvalumab · PD-L113 weeks
Imjudo
tremelimumab · CTLA-426 weeks
Jemperli
dostarlimab · PD-113 weeks
Kevzara
sarilumab · IL-6R26 weeks
Keytruda
pembrolizumab · PD-126 weeks
Kisunla
donanemab · Amyloid-β (N3pG)22 weeks
Lartruvo
olaratumab · PDGFRα39 weeks
Leqembi
lecanemab · Amyloid-β protofibrils39 weeks
Libtayo
cemiplimab · PD-126 weeks
Loqtorzi
toripalimab · PD-126 weeks
Lucentis
ranibizumab · VEGF-A26 weeks
Monjuvi
tafasitamab · CD1913 weeks
Nemluvio
nemolizumab · IL-31RA26 weeks
Niktimvo
axatilimab · CSF-1R26 weeks
Nucala
mepolizumab · IL-526 weeks
Ocrevus
ocrelizumab · CD2024 weeks
Omvoh
mirikizumab · IL-23 p1926 weeks
Opdivo
nivolumab · PD-113 weeks
Pasatru
garetosmab · Activin A26 weeks
Penpulimab
penpulimab · PD-113 weeks
Perjeta
pertuzumab · HER226 weeks
Piasky
crovalimab · Complement C526 weeks
Portrazza
necitumumab · EGFR26 weeks
Poteligeo
mogamulizumab · CCR426 weeks
Praluent
alirocumab · PCSK926 weeks
Praxbind
idarucizumab · Dabigatran4 weeks
Prolia
denosumab · RANKL52 weeks
Raxibacumab
raxibacumab · B. anthracis protective antigen3 weeks
Remicade
infliximab · TNF-α26 (mouse surrogate antibody)
Repatha
evolocumab · PCSK926 weeks
Rituxan
rituximab · CD208 weeks
Rystiggo
rozanolixizumab · FcRn26 weeks
Saphnelo
anifrolumab · IFNAR139 weeks
Sarclisa
isatuximab · CD383 weeks
Siliq
brodalumab · IL-17RA26 weeks
Simponi
golimumab · TNF-α26 weeks
Simulect
basiliximab · IL-2Rα (CD25)4 weeks
Skyrizi
risankizumab · IL-23 p1926 weeks
Soliris
eculizumab · Complement C526 weeks
Spevigo
spesolimab · IL-36R26 weeks
Stelara
ustekinumab · IL-12/23 p4026 weeks
Sylvant
siltuximab · IL-626 weeks
Synagis
palivizumab · RSV F protein0 (no repeat-dose studies; single-dose only)
Takhzyro
lanadelumab · Plasma kallikrein26 weeks
Taltz
ixekizumab · IL-17A39 weeks
Tecentriq
atezolizumab · PD-L126 weeks
Tepezza
teprotumumab · IGF-1R39 weeks
Tevimbra
tislelizumab · PD-113 weeks
Tezspire
tezepelumab · TSLP26 weeks
Tremfya
guselkumab · IL-23 p1924 weeks
Trogarzo
ibalizumab · CD439 weeks
Tysabri
natalizumab · α4-integrin26 weeks
Tzield
teplizumab · CD31 weeks
Ultomiris
ravulizumab · Complement C526 weeks
Unituxin
dinutuximab · GD24 weeks
Unloxcyt
cosibelimab · PD-L113 weeks
Uplizna
inebilizumab · CD1926 weeks
Vectibix
panitumumab · EGFR26 weeks
Veopoz
pozelimab · Complement C526 weeks
Voyxact
sibeprenlimab · APRIL26 weeks
Vyepti
eptinezumab · CGRP26 weeks
Vyloy
zolbetuximab · Claudin 18.213 weeks
Xolair
omalizumab · IgE26 weeks
Yartemlea
narsoplimab · MASP-226 weeks
Yervoy
ipilimumab · CTLA-426 weeks
Zinbryta
daclizumab · IL-2Rα (CD25)39 weeks
Zinplava
bezlotoxumab · C. difficile toxin B3 weeks
Zynyz
retifanlimab · PD-113 weeks
Beovu
brolucizumab · VEGF-ANot stated in public reviews