Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Vabysmo: genotox, carcinogenicity and repro: done or skipped?
faricimab · VEGF-A x Ang-2
Genotoxicity
Not conducted (ICH S6(R1))
“In accordance with ICH S6(R1) guidance, standard genotoxicity studies were not conducted with faricimab.”
Carcinogenicity
Not conducted (no rodent VEGF-A binding); weight-of-evidence carcinogenicity assessment document
“No standard rodent carcinogenicity studies have been conducted as faricimab showed no relevant binding to mouse or rat VEGF-A.”
Instead of carcinogenicity
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Instead of genotoxicity
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
DRG histopathology
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Reproductive & developmental
Monkey EFD (IV, GD20-48): non-dose-dependent increase in abortions, no NOAEL; fertility via 6-month study organ histology
“An embryofetal development (EFD) study in cynomolgus monkeys showed an increase incidence of abortions in faricimab treated monkeys at IV doses of 1 or 3 mg/kg administered weekly on gestation days 20 to 48.”
Safety pharmacology
No stand-alone studies; endpoints in 2-month and 6-month monkey tox studies
“Stand-alone safety pharmacology studies were not performed.”
Genotox: Ames
Not conducted (ICH S6(R1))
“In accordance with ICH S6(R1) guidance, standard genotoxicity studies were not conducted with faricimab.”
Genotox: in vitro mammalian
Not conducted (ICH S6(R1))
“In accordance with ICH S6(R1) guidance, standard genotoxicity studies were not conducted with faricimab.”
Genotox: in vivo
Not conducted (ICH S6(R1))
“In accordance with ICH S6(R1) guidance, standard genotoxicity studies were not conducted with faricimab.”
Carcinogenicity model
Not conducted; carcinogenicity assessment document (weight of evidence)
“No standard rodent carcinogenicity studies have been conducted as faricimab showed no relevant binding to mouse or rat VEGF-A.”
Carcinogenicity timing
Not required; weight of evidence does not suggest carcinogenic potential
“No standard rodent carcinogenicity studies have been conducted as faricimab is not fully cross-reactive in rodents. The intended anti-angiogenic effects of faricimab and the weight of evidence do not suggest a carcinogenic potential of faricimab.”
hERG / QT
No hERG assay; monkey telemetry ECG incl. QT/QTc comparable to controls
“In both studies, heart rate and ECG endpoints, including QT and QTc, were comparable between control and faricimab-dosed groups.”
Same question, other multispecifics
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))
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)Not conducted (ICH S6(R1), ICH S9)