Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Elrexfio: genotox, carcinogenicity and repro: done or skipped?
elranatamab · BCMA x CD3
Genotoxicity
Not conducted (ICH S6(R1))
“Genotoxicity studies with elranatamab have not been conducted since they are generally not required for protein-based biotherapeutics per ICH S6(R1).”
Carcinogenicity
Not conducted (ICH S9 / S6(R1))
“Carcinogenicity studies with elranatamab have not been conducted since they are generally not required for advanced cancer and protein-based biotherapeutics per ICH S9 and ICH S6(R1), respectively.”
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
Not conducted (weight-of-evidence); reproductive organs assessed in 3-month monkey study, no effects
“Embryofetal developmental toxicity was evaluated using a weight of evidence (WOE) risk assessment”
Safety pharmacology
Incorporated into repeat-dose monkey studies (ECG, heart rate; respiratory/CNS by clinical observation)
“No safety pharmacology studies were conducted. Safety pharmacology was evaluated as part of the general toxicology studies performed with elranatamab.”
Genotox: Ames
Not conducted (ICH S6)
“Genotoxicity studies with elranatamab have not been conducted since they are generally not required for protein-based biotherapeutics per ICH S6(R1).”
Genotox: in vitro mammalian
Not conducted (ICH S6)
“Genotoxicity studies with elranatamab have not been conducted since they are generally not required for protein-based biotherapeutics per ICH S6(R1).”
Genotox: in vivo
Not conducted (ICH S6)
“Genotoxicity studies with elranatamab have not been conducted since they are generally not required for protein-based biotherapeutics per ICH S6(R1).”
Carcinogenicity model
Not conducted (ICH S9, ICH S6(R1))
“Carcinogenicity studies with elranatamab have not been conducted since they are generally not required for advanced cancer and protein-based biotherapeutics per ICH S9 and ICH S6(R1), respectively.”
Carcinogenicity timing
Not required for advanced cancer and protein-based biotherapeutics
“Carcinogenicity studies with elranatamab have not been conducted since they are generally not required for advanced cancer and protein-based biotherapeutics per ICH S9 and ICH S6(R1), respectively.”
hERG / QT
No hERG assay; no ECG or heart rate effects in monkey toxicology studies
“We agree that the safety pharmacology assessment in the toxicology studies in cynomolgus monkeys did not show elranatamab induced effects on cardiovascular endpoints (ECG or heart rate).”
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))
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)