Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Ordspono: genotox, carcinogenicity and repro: done or skipped?
odronextamab · CD20 x CD3
Genotoxicity
Not conducted (antibody not expected to interact with DNA)
“Antibodies, such as odronextamab, are not expected to interact directly with DNA or other chromosomal material. Therefore, no genotoxicity studies were conducted with odronextamab.”
Carcinogenicity
Not conducted (ICH S9, advanced malignancy)
“As odronextamab is intended for use in patients with advanced malignancies, carcinogenicity studies were not conducted with odronextamab”
Reproductive & developmental
No EFD study; fertility endpoints in 16-week monkey study unaffected; risk assessment in lieu (fetal B-cell lymphocytopenia, CRS)
“Embryo-fetal developmental toxicology studies with odronextamab were not conducted as such studies are expected to have limited value in further understanding and communicating risks to patients with advanced cancer.”
Safety pharmacology
Integrated into 4- and 16-week GLP monkey studies up to 1 mg/kg; no changes
“No changes on safety pharmacology endpoints were detected.”
Same question, other bispecifics
Blincyto
blinatumomab · CD19 x CD3Not conducted (ICH S6(R1); protein of natural amino acids)
Columvi
glofitamab · CD20 x CD3Not conducted (ICH S6(R1))
Elrexfio
elranatamab · BCMA x CD3Not conducted (ICH S6(R1))
Epkinly
epcoritamab · CD20 x CD3Not conducted (ICH S6(R1), ICH S9)
Hemlibra
emicizumab · FIXa x FXNot conducted (ICH S6)
Imdelltra
tarlatamab · DLL3 x CD3Not conducted (ICH S6(R1))
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)Not conducted (fusion protein; ICH S6/S9)
Korjuny
catumaxomab · EpCAM x CD3Not conducted (ICH S6(R1))
Lunsumio
mosunetuzumab · CD20 x CD3Not conducted (ICH S6(R1))
Lynozyfic
linvoseltamab · BCMA x CD3Not conducted (antibody not expected to interact with DNA)
Removab
catumaxomab · EpCAM x CD3Not conducted (not submitted; biologic, no relevant model)
Rybrevant
amivantamab · EGFR x METNot conducted (not appropriate for antibodies)
Talvey
talquetamab · GPRC5D x CD3Not conducted (ICH S6; biotechnology-derived product)
Tecvayli
teclistamab · BCMA x CD3Not conducted (ICH S6(R1))
Vabysmo
faricimab · VEGF-A x Ang-2Not conducted (ICH S6(R1))
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)Not conducted (ICH S6(R1), ICH S9)