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.”
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).”
Same question, other bispecifics
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)