Itovebi: which tox species, and why?

“Inavolisib was evaluated in GLP-compliant, repeat-dose toxicology studies in Sprague-Dawley rats and Beagle dogs following once daily oral administration, consistent with the clinical route of administration and intended dosing schedule, for up to 3 months in duration.”

“The rat and dog were selected as the toxicology species based on high protein homology of the target, the demonstration of in vivo pharmacodynamics, adequate in vivo exposure, and comparable in vivo metabolic profile to humans.”

“Inavolisib was assessed in a series of non-clinical toxicology studies in rats and dogs.”

“Inavolisib was evaluated in GLP-compliant, repeat-dose toxicology studies in Sprague-Dawley rats and Beagle dogs following once daily oral administration, consistent with the clinical route of administration and intended dosing schedule, for up to 3 months in duration.”

“In a GLP-compliant preliminary embryo-fetal development study, pregnant rats received oral doses of inavolisib up to 6 mg/kg/day during the period of organogenesis from gestational day”

“Carcinogenicity studies were not conducted, nor warranted, with inavolisib to support the proposed indication in patients with advanced cancer in accordance with ICH S9 guidance.”

“Inavolisib was assessed in a series of non-clinical toxicology studies in rats and dogs.”