Fruzaqla: how long were the pivotal tox studies?

“Given the indication was in the scope of ICH S9 guideline, the two 13-week GLP compliant studies could be considered as the only pivotal studies in the submitted non-clinical package.”

“Overall, the toxicity profile determined in rat and dog in the non-GLP studies (4-week studies and 26 or 39-week studies with an intermediate 13-week analysis) appears affected a larger number of target organs than the one observed in GLP pivotal studies (two 13-week studies).”

“In a 13-week repeat-dose toxicology study in rats, animals were orally administered fruquintinib at 0, 0.3, 0.6, or 1.2 mg/kg daily with a 4-week recovery period.”