Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Hemlibra: genotox, carcinogenicity and repro: done or skipped?
emicizumab · FIXa x FX
Genotoxicity
Not conducted (ICH S6)
“Genotoxicity studies were not conducted as these types of studies are not applicable to biotechnology-derived pharmaceuticals (per ICH S6).”
Carcinogenicity
Not conducted (no pharmacologically relevant rodent; waived with ECAC concurrence)
“Carcinogenicity studies were not conducted due to lack of a pharmacologically relevant rodent species.”
Reproductive & developmental
Not conducted (99% of patients male); no reproductive organ effects in 26-week monkey study
“Animal reproductive and developmental toxicology studies were not conducted with emicizumab as hemophilia A is inherited in an X-linked recessive manner.”
Safety pharmacology
Incorporated into repeat-dose monkey studies (ICH S6(R1)); no CNS, respiratory or CV effects
“Safety assessment of vital organs was incorporated in the toxicology studies in monkeys.”
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)
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))
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)Not conducted (ICH S6(R1), ICH S9)