Modeyso: which tox species, and why?

“The Applicant evaluated the safety of dordaviprone administered orally once or twice weekly in 28-day and 13-week GLP-compliant general toxicology studies using Sprague Dawley rats and Beagle dogs.”

“in both rodents (Sprague-Dawley rats) and nonrodents (Beagle dogs) (Studies ONC201-TX-100, ONC201-TX-101; m4.2.3.2). This program was consistent with ICH S9, the guideline for nonclinical evaluation for anticancer pharmaceuticals (ICH 2010).”

“The toxicity profile of orally administered dordaviprone was defined in GLP-regulated studies with once or twice (on 2 consecutive days) weekly administration for up to 13 weeks”

“The Applicant evaluated the safety of dordaviprone administered orally once or twice weekly in 28-day and 13-week GLP-compliant general toxicology studies using Sprague Dawley rats and Beagle dogs.”

“The FDA agreed that due to the significant findings in the non-GLP dose-range finding embryo-fetal development studies in rats and rabbits that additional GLP-compliant studies do not need to be conducted.”

“The FDA agrees that carcinogenicity studies are not warranted for the current indication of pediatric and adult patients with H3 K27M-mutant diffuse glioma.”

“The Applicant evaluated the safety of dordaviprone administered orally once or twice weekly in 28-day and 13-week GLP-compliant general toxicology studies using Sprague Dawley rats and Beagle dogs.”