Empliciti: which tox species, and why?

“Due to the lack of a pharmacologically-relevant animal species to conduct toxicology studies, the scope of the toxicological evaluation for elotuzumab was limited to a tissue cross-reactivity study and in vivo studies that assessed the potential for off-target toxicity and local tolerance.”

“HuLuc63 specifically binds only to human CS1 and does not recognize CS1 from the mouse or any NHP species tested (see Figure 5).”

“However, the mouse characterization results indicated that the human SLAMF7 transgenic mouse was not a valid alternative animal model for toxicology testing due to a lack of human SLAMF7 expression in both resting and activated T cells in this mouse model as compared to humans.”

“Repeat-dose toxicity studies of elotuzumab were not conducted due to the lack of a relevant toxicology species or a valid transgenic mouse model.”

“No reproductive and developmental toxicology studies were conducted due to the lack of a pharmacologically-relevant animal species.”

“No carcinogenicity studies were conducted. Carcinogenicity studies are not necessary to support the marketing of therapeutics intended to treat patients with advanced cancer as discussed in the ICH S9 guidance document”

“However, the mouse characterization results indicated that the human SLAMF7 transgenic mouse was not a valid alternative animal model for toxicology testing due to a lack of human SLAMF7 expression in both resting and activated T cells in this mouse model as compared to humans.”