Beqalzi: which tox species, and why?

“The GLP-compliant repeat-dose toxicology studies of up to 13 weeks of dosing were conducted in mice and dogs with animals dosed daily via oral gavage.”

“Mice and dogs were pharmacologically relevant species for toxicity evaluation, based on their high BCL2 sequence homology with humans, comparable metabolism profiles with humans in in vitro studies, and adequate bioavailability.”

“In the 13-week dog study, sonrotoclax was administered at doses of 10, 30, or 100 mg/kg/day.”

“The GLP-compliant repeat-dose toxicology studies of up to 13 weeks of dosing were conducted in mice and dogs with animals dosed daily via oral gavage.”

“In animal reproduction studies, oral administration of sonrotoclax to pregnant mice and rabbits during the period of organogenesis resulted in adverse developmental outcomes, including structural abnormalities and altered fetal growth”

“No carcinogenicity studies were conducted. These studies were not required for an oncology drug intended for treatment of patients with severe or life-threatening malignancies per ICH S9 guidance.”

“Mice and dogs were pharmacologically relevant species for toxicity evaluation, based on their high BCL2 sequence homology with humans”