Tabrecta: how long were the pivotal tox studies?

“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.”

“Pivotal repeat dose toxicity studies were conducted in rats and monkeys for a 4- and 13-week dosing period.”

“The oral route was chosen because it is the intended route of administration in humans.”