Bizengri
zenocutuzumab · HER2 x HER3Not conducted (ICH S6(R1))
Rybrevant: genotox, carcinogenicity and repro: done or skipped?
amivantamab · EGFR x MET
Genotoxicity
Not conducted (not appropriate for antibodies)
“Janssen did not conduct genetic toxicology studies as they are not appropriate for antibody therapies.”
Carcinogenicity
Not conducted (advanced cancer, ICH S9)
“In addition, Janssen did not conduct dedicated studies to assess fertility or carcinogenicity as these studies are not necessary to support the development of a drug intended to treat patients with advanced cancer.”
Reproductive & developmental
Not conducted; weight-of-evidence (EGFR/MET knockouts, lazertinib rat EFD, zalutumumab monkey EFD); embryofetal warning
“Rather than conducting a dedicated embryofetal development study, Janssen provided a weight-of-evidence-based assessment of the potential for amivantamab to cause reproductive and embryofetal toxicity.”
Safety pharmacology
Incorporated into 1-month, 6-week and 3-month monkey studies (CV, respiratory, observational CNS)
“Separate safety pharmacology studies were not conducted with amivantamab; however, the 1-month non-Good Laboratory Practice (GLP) tolerability study, and the 6-week and the 3-month toxicity GLP studies in cynomolgus monkeys incorporated cardiovascular and respiratory assessments as well as observational central nervous system (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)
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)