Tabrecta: which tox species, and why?

“The Applicant evaluated the toxicity profile of capmatinib in GLP-compliant studies in Sprague-Dawley rats and Cynomolgus monkeys with durations of treatment of up to 13 weeks.”

“The rat and monkey were selected as the rodent and non-rodent species, respectively, for repeat-dose toxicity testing because both have historically been used in safety evaluations, and both species have a highly conserved MET receptor target protein sequence.”

“The Applicant evaluated the toxicity profile of capmatinib in GLP-compliant studies in Sprague-Dawley rats and Cynomolgus monkeys with durations of treatment of up to 13 weeks.”

“The Applicant evaluated the toxicity profile of capmatinib in GLP-compliant studies in Sprague-Dawley rats and Cynomolgus monkeys with durations of treatment of up to 13 weeks.”

“To address the potential reproductive effects of capmatinib, Novartis conducted embryo-fetal development studies in rats and rabbits.”

“Carcinogenicity studies were not conducted for capmatinib or necessary for a drug intended for the treatment of patients with advanced cancer.”

“The Applicant evaluated the toxicity profile of capmatinib in GLP-compliant studies in Sprague-Dawley rats and Cynomolgus monkeys with durations of treatment of up to 13 weeks.”