Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Kimmtrak: genotox, carcinogenicity and repro: done or skipped?
tebentafusp · CD3 x gp100 (TCR fusion)
Genotoxicity
Not conducted (fusion protein; ICH S6/S9)
“Based on the biologic properties of tebentafusp, a fusion protein, genetic toxicology studies are not warranted.”
Carcinogenicity
Not conducted (advanced cancer indication)
“Carcinogenicity studies were not warranted for the proposed indication.”
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 (no relevant species); weight-of-evidence; FDA concluded possible fetal harm to skin, inner ear, eye
“Due to the specificity for human targets, embryo-fetal development (EFD) studies cannot be conducted in nonclinical species. Therefore, a weight of evidence assessment was conducted to evaluate the risk of tebentafusp administration on pregnancy and embryo-fetal development.”
Safety pharmacology
Not conducted (no relevant species; in vitro only)
“Therefore, no specific safety pharmacology studies were conducted.”
Genotox: Ames
Not conducted (ICH S6)
“Genetic toxicology studies were not conducted for tebentafusp in accordance with the ICH S6 guidance.”
Genotox: in vitro mammalian
Not conducted (ICH S6)
“Genetic toxicology studies were not conducted for tebentafusp in accordance with the ICH S6 guidance.”
Genotox: in vivo
Not conducted (ICH S6)
“Genetic toxicology studies were not conducted for tebentafusp in accordance with the ICH S6 guidance.”
Carcinogenicity model
Not conducted (not warranted for the advanced-cancer indication)
“The FDA’s Assessment: Carcinogenicity studies were not warranted for the proposed indication.”
Carcinogenicity timing
Not required for the proposed indication
“The FDA’s Assessment: Carcinogenicity studies were not warranted for the proposed indication.”
hERG / QT
Not conducted (no relevant species; human-specific protein)
“Safety pharmacology studies were not conducted for tebentafusp. Tebentafusp is a human specific protein and does not bind proteins from nonhuman species.”
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))
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)