Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Tecvayli: genotox, carcinogenicity and repro: done or skipped?
teclistamab · BCMA x CD3
Genotoxicity
Not conducted (ICH S6(R1))
“Genotoxicity studies were not conducted with teclistamab.”
Carcinogenicity
Not conducted (ICH S9, advanced cancer)
“Carcinogenicity studies were not conducted with teclistamab.”
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 assessment (BCMA biology, knockout mice); no reproductive tissue findings in 5-week study
“No reproductive and developmental toxicity studies were conducted for teclistamab.”
Safety pharmacology
Incorporated into 5-week GLP monkey study (CV, respiratory, observational CNS); no effects
“Separate safety pharmacology studies were not conducted with teclistamab; however, the 5-week GLP study in cynomolgus monkey incorporated cardiovascular, respiratory as well as observational CNS assessments (body temperature and clinical signs).”
Genotox: Ames
Not conducted (ICH S6(R1))
“Genotoxicity studies were not conducted with teclistamab.”
Genotox: in vitro mammalian
Not conducted (ICH S6(R1))
“Genotoxicity studies were not conducted with teclistamab.”
Genotox: in vivo
Not conducted (ICH S6(R1))
“Genotoxicity studies were not conducted with teclistamab.”
Carcinogenicity model
Not conducted (ICH S9, advanced cancer)
“Carcinogenicity studies were not conducted with teclistamab. As indicated in the ICH S9 guidance, carcinogenicity studies are not warranted to support marketing for therapeutics intended to treat patients with advanced cancer.”
Carcinogenicity timing
Not required; FDA agreed carcinogenicity studies not needed
“We agree that carcinogenicity studies are not needed to support the approval of BLA 761261.”
hERG / QT
No hERG assay; no cardiovascular effects in monkey up to 30 mg/kg/week
“There were no teclistamab-related effects on examined cardiovascular, respiratory, or CNS parameters associated with IV administration up to 30 mg/kg/week in cynomolgus monkey.”
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)
Vabysmo
faricimab · VEGF-A x Ang-2Not conducted (ICH S6(R1))
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)Not conducted (ICH S6(R1), ICH S9)