Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Ziihera: genotox, carcinogenicity and repro: done or skipped?
zanidatamab · HER2 x HER2 (biparatopic)
Genotoxicity
Not conducted (ICH S6(R1), ICH S9)
“Thus, mutagenicity studies are considered inappropriate and were not conducted.”
Carcinogenicity
Not conducted (ICH S9; advanced cancer, no mechanistic concern)
“Thus, given the intended patient population and lack of mechanistic concern, carcinogenicity studies are not planned with zanidatamab (ICH S9)”
Reproductive & developmental
Not conducted; weight-of-evidence, HER2 antibody class embryo-fetal toxicant (oligohydramnios)
“Consequently, the conduct of de novo developmental and reproductive toxicity (DART) studies is not warranted for zanidatamab.”
Safety pharmacology
Incorporated into 13-week monkey study (CV, respiratory, CNS); no effects
“Stand-alone safety pharmacology studies were not performed; however, appropriate safety assessments were included in the 13- week repeat-dose toxicology study”
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)
Ordspono
odronextamab · CD20 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))