Komzifti: which tox species, and why?

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

“In vitro metabolism in liver microsomes from the toxicological test species, mouse and dog, and humans was similar and there were no unique human metabolites.”

“In the 13-week toxicology study in dogs, animals were given ziftomenib at doses of 6, 20, or 60 mg/kg/day.”

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

“Fertility studies in animals have not been conducted with ziftomenib.”

“No carcinogenicity studies have been conducted with ziftomenib. The FDA’s Assessment: The FDA concurs. Carcinogenicity studies were not warranted for the proposed indication.”

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