Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Blincyto: genotox, carcinogenicity and repro: done or skipped?
blinatumomab · CD19 x CD3
Genotoxicity
Not conducted (ICH S6(R1); protein of natural amino acids)
“In vitro and in vivo genotoxicity studies were not performed in accordance with ICH S6 (R1).”
Carcinogenicity
Not conducted (ICH S9, advanced cancer indication)
“As it is being developed for advanced cancer indications, no carcinogenicity studies have been conducted, in accordance with ICH S9.”
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
Mouse EFD with surrogate: placental transfer, no embryo-fetal toxicity or teratogenicity; no fertility studies
“Studies in mice using the surrogate showed no drug-related effects in male or female reproductive organs and did not reveal any embryo-fetal toxicity or teratogenicity.”
Safety pharmacology
CNS (Irwin, ICV infusion) and respiratory studies in mice with surrogate; CV in chimpanzee tox studies
“To evaluate the potential effects on the central nervous system (CNS), two CNS safety pharmacology studies were conducted with the murine surrogate muS103new in mice.”
Genotox: Ames
Not conducted (ICH S6)
“In vitro and in vivo genotoxicity studies were not performed in accordance with ICH S6 (R1).”
Genotox: in vitro mammalian
Not conducted (ICH S6)
“In vitro and in vivo genotoxicity studies were not performed in accordance with ICH S6 (R1).”
Genotox: in vivo
Not conducted (ICH S6)
“In vitro and in vivo genotoxicity studies were not performed in accordance with ICH S6 (R1).”
Carcinogenicity model
Not conducted (advanced cancer indication, ICH S9)
“As it is being developed for advanced cancer indications, no carcinogenicity studies have been conducted, in accordance with ICH S9.”
Carcinogenicity timing
Not required for advanced cancer indication (ICH S9)
“As it is being developed for advanced cancer indications, no carcinogenicity studies have been conducted, in accordance with ICH S9.”
hERG / QT
No hERG or QT data stated; cardiovascular monitoring in 6 chimpanzees showed hypotension, possibly cytokine-related
“Cardiovascular function was monitored during the toxicity studies performed with blinatumomab in a total of 6 chimpanzees. Changes in blood pressure (hypotension) were observed in some animals and may be related to a treatment-related increase in cytokine levels.”
Same question, other multispecifics
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))
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)Not conducted (ICH S6(R1), ICH S9)